Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications, 15686-15691 [2021-06052]
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15686
Federal Register / Vol. 86, No. 55 / Wednesday, March 24, 2021 / Notices
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
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‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
FOR FURTHER INFORMATION CONTACT:
Kristle Green, Office of Compliance,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993, 301–
796–3130, CDERODSIRPublicMeetings@
fda.hhs.gov.
In the
Federal Register of October 28, 2020 (85
FR 68342), FDA published a notice with
a 60-day comment period to announce
and request comments on a virtual
public meeting entitled ‘‘The Drug
Supply Chain Security Act Pilot Project
Program and Enhanced Drug
Distribution Security’’ held on
December 8 and 9, 2020. FDA is
reopening the comment period until
June 22, 2021.
The Agency believes that an
additional 90 days will allow adequate
time for interested persons to submit
comments. Materials from the public
meeting are on FDA’s website at https://
www.fda.gov/drugs/news-eventshuman-drugs/drug-supply-chainsecurity-act-pilot-project-program-andenhanced-drug-distribution-security.
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SUPPLEMENTARY INFORMATION:
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Dated: March 19, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–06053 Filed 3–23–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2018–M–3841, FDA–
2018–M–3842, FDA–2018–M–3983, FDA–
2018–M–4033, FDA–2018–M–4205, FDA–
2018–M–4580, FDA–2018–M–4582, FDA–
2018–M–4665, FDA–2018–M–4777, FDA–
2018–M–4778, FDA–2018–M–4779, FDA–
2018–M–4780, FDA–2018–M–4916, FDA–
2019–M–0027, FDA–2019–M–0028, FDA–
2019–M–0505, FDA–2019–M–0645, FDA–
2019–M–0802, FDA–2019–M–0885, FDA–
2019–M–0995, FDA–2019–M–1214, FDA–
2019–M–1251, FDA–2019–M–1310, FDA–
2019–M–1313, FDA–2019–M–1465, FDA–
2019–M–1506, FDA–2019–M–1582, FDA–
2019–M–1763, FDA–2019–M–1848, FDA–
2019–M–1979, FDA–2019–M–1998, FDA–
2019–M–2052, FDA–2019–M–2193, FDA–
2019–M–2408, FDA–M–2522, FDA–2019–M–
2560, FDA–2019–M–2561, FDA–2019–M–
2671, FDA–2019–M–2732, FDA–2019–M–
2753, FDA–2019–M–2782, FDA–2019–M–
3309, FDA–2019–M–3513, FDA–2019–M–
3652, FDA–2019–M–3845, FDA–2019–M–
3863, FDA–2019–M–3844, FDA–2019–M–
4007, FDA–2019–M–4153, FDA–2019–M–
4186, FDA–2019–M–4238, FDA–2019–M–
4928, FDA–2019–M–4978, FDA–2019–M–
5393, FDA–2019–M–5438, FDA–2019–M–
5534, FDA–2019–M–5605, FDA–2019–M–
5683, FDA–2019–M–5741, FDA–2019–M–
5857, FDA–2019–M–5961, FDA–2020–M–
0097, FDA–2020–M–0107, FDA–2020–M–
0108, FDA–2020–M–0495, FDA–2020–M–
0985, FDA–2020–M–0984, FDA–2020–M–
0986, FDA–2020–M–1083, FDA–2020–M–
1115, FDA–2020–M–1116, FDA–2020–M–
1175, FDA–2020–M–1213, FDA–2020–M–
1214, FDA–2020–M–1267, FDA–2020–M–
1286, FDA–2020–M–1290, FDA–2020–M–
1299, FDA–2020–M–1300, FDA–2020–M–
1311, FDA–2020–M–1358, FDA–2020–M–
1367, FDA–2020–M–1410, FDA–2020–M–
1420, FDA–2020–M–1527, FDA–2020–M–
1583, FDA–2020–M–1600, FDA–2020–M–
1612, FDA–2020–M–1613, FDA–2020–M–
1715, FDA–2020–M–1724, FDA–2020–M–
1726, FDA–2020–M–1748, FDA–2020–M–
1752, FDA–2020–M–1760, FDA–2020–M–
1821, FDA–2020–M–1783, FDA–2020–M–
1822, FDA–2020–M–1828, FDA–2020–M–
1830, FDA–2020–M–1829, FDA–2020–M–
1835, FDA–2020–M–1838, FDA–2020–M–
1868, FDA–2020–M–1986, FDA–2020–M–
2021, FDA–2020–M–2288, FDA–2020–M–
2248, and FDA–2020–M–2339]
Medical Devices; Availability of Safety
and Effectiveness Summaries for
Premarket Approval Applications
AGENCY:
Food and Drug Administration,
HHS.
PO 00000
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ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
publishing a list of premarket approval
applications (PMAs) that have been
approved from October 1, 2018, through
December 31, 2020. This list is intended
to inform the public of the availability
of safety and effectiveness summaries of
approved PMAs through the internet
and the Agency’s Dockets Management
Staff.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket Nos. FDA–
2018–M–3841, FDA–2018–M–3842,
FDA–2018–M–3983, FDA–2018–M–
4033, FDA–2018–M–4205, FDA–2018–
M–4580, FDA–2018–M–4582, FDA–
E:\FR\FM\24MRN1.SGM
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2018–M–4665, FDA–2018–M–4777,
FDA–2018–M–4778, FDA–2018–M–
4779, FDA–2018–M–4780, FDA–2018–
M–4916, FDA–2019–M–0027, FDA–
2019–M–0028, FDA–2019–M–0505,
FDA–2019–M–0645, FDA–2019–M–
0802, FDA–2019–M–0885, FDA–2019–
M–0995, FDA–2019–M–1214, FDA–
2019–M–1251, FDA–2019–M–1310,
FDA–2019–M–1313, FDA–2019–M–
1465, FDA–2019–M–1506, FDA–2019–
M–1582, FDA–2019–M–1763, FDA–
2019–M–1848, FDA–2019–M–1979,
FDA–2019–M–1998, FDA–2019–M–
2052, FDA–2019–M–2193, FDA–2019–
M–2408, FDA–2019–M–2522, FDA–
2019–M–2560, FDA–2019–M–2561,
FDA–2019–M–2671, FDA–2019–M–
2732, FDA–2019–M–2753, FDA–2019–
M–2782, FDA–2019–M–3309, FDA–
2019–M–3513, FDA–2019–M–3652,
FDA–M–3845, FDA–2019–M–3862,
FDA–2019–M–3863, FDA–2019–M–
3844, FDA–2019–M–4007, FDA–2019–
M–4153, FDA–2019–M–4186, FDA–
2019–M–4238, FDA–2019–M–4928,
FDA–2019–M–4978, FDA–2019–M–
5393, FDA–2019–M–5438, FDA–2019–
M–5534, FDA–2019–M–5605, FDA–
2019–M–5683, FDA–2019–M–5741,
FDA–2019–M–5857, FDA–2019–M–
5961, FDA–2020–M–0097, FDA–2020–
M–0107, FDA–2020–M–0108, FDA–
2020–M–0495, FDA–2020–M–0985,
FDA–2020–M–0984, FDA–2020–M–
0986, FDA–2020–M–1083, FDA–2020–
M–1115, FDA–2020–M–1116, FDA–
2020–M–1175, FDA–2020–M–1213,
FDA–2020–M–1214, FDA–2020–M–
1267, FDA–2020–M–1286, FDA–2020–
M–1290, FDA–2020–M–1299, FDA–
2020–M–1300, FDA–2020–M–1311,
FDA–2020–M–1358, FDA–2020–M–
1367, FDA–2020–M–1410, FDA–2020–
M–1420, FDA–2020–M–1527, FDA–
2020–M–1583, FDA–2020–M–1600,
FDA–2020–M–1612, FDA–2020–M–
1613, FDA–2020–M–1715, FDA–2020–
M–1724, FDA–2020–M–1726, FDA–
2020–M–1748, FDA–2020–M–1752,
FDA–2020–M–1760, FDA–2020–M–
1821, FDA–2020–M–1783, FDA–2020–
M–1822, FDA–2020–M–1828, FDA–
2020–M–1830, FDA–2020–M–1829,
FDA–2020–M–1835, FDA–2020–M–
1838, FDA–2020–M–1868, FDA–2020–
M–1986, FDA–2020–M–2021, FDA–
2020–M–2288, FDA–2020–M–2248, and
FDA–2020–M–2339 for ‘‘Medical
Devices; Availability of Safety and
Effectiveness Summaries for Premarket
Approval Applications.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
15687
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
FOR FURTHER INFORMATION CONTACT:
Dharmesh Patel, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2434, Silver Spring,
MD 20993–0002, 301–796–3289.
SUPPLEMENTARY INFORMATION:
I. Background
In accordance with section 515(d)(4)
and (e)(2) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
360e(d)(4) and (e)(2)), notification of an
order approving, denying, or
withdrawing approval of a PMA will
continue to include a notice of
opportunity to request review of the
order under section 515(g) of the FD&C
Act. The 30-day period for requesting
reconsideration of an FDA action under
§ 10.33(b) (21 CFR 10.33(b)) for notices
announcing approval of a PMA begins
on the day the notice is published in the
Federal Register. Section 10.33(b)
provides that FDA may, for good cause,
extend this 30-day period.
Reconsideration of a denial or
withdrawal of approval of a PMA may
be sought only by the applicant; in these
cases, the 30-day period will begin
when the applicant is notified by FDA
in writing of its decision.
The regulations provide that FDA
publish a list of available safety and
effectiveness summaries of PMA
approvals and denials that were
announced. The following is a list of
approved PMAs for which summaries of
safety and effectiveness were placed on
the internet from October 1, 2018,
through December 31, 2020. There were
no denial actions during this period.
The list provides the manufacturer’s
name, the product’s generic name or the
trade name, and the approval date.
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TABLE 1—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS AND SAFETY AND PROBABLE BENEFIT
SUMMARIES FOR APPROVED HDES MADE AVAILABLE FROM OCTOBER 1, 2018, THROUGH DECEMBER 31, 2020
PMA No., Docket No.
Applicant
Trade name
P180003, FDA–2018–M–3841
P150040/S003, FDA–2018–
M–3842.
P160054/S008, FDA–2018–
M–3983.
P100040/S036, FDA–2018–
M–4033.
P180010, FDA–2018–M–4205
P150002, FDA–2018–M–4580
Veryan Medical Ltd ................
Carl Zeiss Meditec, Inc ..........
BioMimics 3D Vascular Stent System ....................................
VisuMax Femtosecond Laser ..................................................
10/4/2018
10/4/2018
Thoratec Corp ........................
HeartMate 3 Left Ventricular Assist System ...........................
10/18/2018
Medtronic Vascular .................
Valiant NavionTM Thoracic Stent Graft System ......................
10/19/2018
W.L. Gore & Associates, Inc ..
Cordis Corp ............................
GORE Carotid Stent ................................................................
Cordis INCRAFT® AAA Stent Graft System ...........................
11/1/2018
11/27/2018
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Federal Register / Vol. 86, No. 55 / Wednesday, March 24, 2021 / Notices
TABLE 1—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS AND SAFETY AND PROBABLE BENEFIT
SUMMARIES FOR APPROVED HDES MADE AVAILABLE FROM OCTOBER 1, 2018, THROUGH DECEMBER 31, 2020—
Continued
PMA No., Docket No.
Applicant
Trade name
P120016/S024, FDA–2018–
M–4582.
P180007, FDA–2018–M–4665
P160034, FDA–2018–M–4672
P160033, FDA–2018–M–4675
Cardiva Medical, Inc ...............
VASCADE® MVP Venous Vascular Closure System .............
11/27/2018
Spiration, Inc ..........................
Cardiac Science Corp ............
Cardiac Science Corp ............
Spiration® Valve System .........................................................
Powerheart® G3 Pro AED .......................................................
Powerheart® G5 AED, Powerheart® AED G3 Plus, And
Powerheart® AED G3.
Resolute OnyxTM Zotarolimus-Eluting Coronary Stent System.
Resolute Integrity Zotarolimus-Eluting Coronary Stent System.
PipelineTM Flex Embolization Device ......................................
12/3/2018
12/6/2018
12/7/2018
P160043/S012, FDA–2018–
M–4777.
P110013/S088, FDA–2018–
M–4778.
P100018/S015, FDA–2018–
M–4779.
P150038/S006, FDA–2018–
M–4780.
P170018, FDA–2018–M–4916
P170032, FDA–2019–M–0027
P180001, FDA–2019–M–0028
P170037, FDA–2019–M–0505
P180025, FDA–19M–2526 .....
P170036, FDA–2019–M–0645
P160050, FDA–2019–M–0802
P170030, FDA–2019–M–0885
P170042/S002, FDA–2019–
M–0995.
P160002/S009, FDA–2019–
M–1310.
P180037, FDA–2019–M–1214
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P100009/S028, FDA–2019–
M–1251.
P180036, FDA–2019–M–1313
P180040, FDA–2019–M–1465
P180032, FDA–2019–M–1506
P170027, FDA–2019–M–1582
P180034, FDA–2019–M–1763
P180043, FDA–2019–M–1979
P180024, FDA–2019–M–1848
P180029, FDA–2019–M–1998
P180014, FDA–2019–M–2052
Medtronic Vascular .................
Medtronic Vascular .................
Micro Therapeutics, Inc. d/b/a
ev3 Neurovascular.
InSightec, Inc ..........................
Approval date
12/14/2018
12/14/2018
12/14/2018
12/16/2018
C.R. Bard, Inc .........................
Exablate Model 4000 Types 1.0 and 1.1 System (Exablate
Neuro).
LIFEPAK® CR2 Defibrillator ....................................................
Woven EndoBridge (WEB) Aneurysm Embolization System
Zenith® Dissection Endovascular System ..............................
Sangia Total PSA Test ............................................................
MANTATM Vascular Closure Device .......................................
M6–CTM Artificial Cervical Disc ...............................................
Barricaid® Anular Closure Device (ACD) ................................
Orsiro Sirolimus Eluting Coronary Stent System (Orsiro
Stent System).
COVERATM Vascular Covered Stent ......................................
Ventana Medical System, Inc
VENTANA PD–L1 (SP142) Assay ..........................................
3/8/2019
Bard Peripheral Vascular, Inc.
(BPV).
Abbott Vascular, Inc ...............
VENOVO Venous Stent System .............................................
3/13/2019
3/14/2019
Physio-Control, Inc .................
Sequent Medical, Inc ..............
William Cook Europe ApS ......
OPKO Diagnostics, LLC .........
Essential Medical, Inc ............
Spinal Kinetics LLC ................
Intrinsic Therapeutics .............
Biotronik, Inc ...........................
12/21/2018
12/31/2018
12/31/2018
1/30/2019
2/1/2019
2/6/2019
2/8/2019
2/22/2019
3/1/2019
P180013, FDA–2019–M–2193
P180031, FDA–2019–M–2408
H180002, FDA–2019–M–2522
P190001, FDA–2019–M–2560
P190004, FDA–2019–M–2561
P160013/S002, FDA–2019–
M–2671.
P160036, FDA–2019–M–2732
P160048/S006, FDA–2019–
M–2753.
P160029, FDA–2019–M–2782
Boston Scientific Corp ............
Stryker Neurovascular ............
Novocure, Ltd .........................
QIAGEN GmbH ......................
QIAGEN GmbH ......................
TransMedics, Inc ....................
MitraClip NT Clip Delivery System; MitraClip NTR/XTR Clip
Delivery System.
OPTIMIZER Smart System .....................................................
TRILURONTM ..........................................................................
Cerene® Cryotherapy Device ..................................................
TherOx DownStream System .................................................
Tack Endovascular System® (6F) ...........................................
therascreen® FGFR RGQ RT–PCR Kit ..................................
TransPyloric Shuttle/TransPyloric Shuttle Delivery Device ....
LOTUS EdgeTM Valve System ................................................
XVIVO Perfusion System (XPSTM) with STEEN SolutionTM
Perfusate.
VICI VENOUS STENT® System .............................................
Neuroform Atlas® Stent System .............................................
NovoTTFTM-100L System .......................................................
therascreen PIK3CA RGQ PCR Kit ........................................
therascreen PIK3CA RGQ PCR Kit ........................................
Organ Care System (OCSTM) Lung System ...........................
DT MedTech, LLC ..................
Senseonics, Inc ......................
Hintermann Series H3TM Total Ankle Replacement System ..
Eversense Continuous Glucose Monitoring System ...............
6/4/2019
6/6/2019
Philips Medical Systems, Inc
6/6/2019
P150013/S014,
M–3309.
P000025/S104,
M–3513.
P150013/S016,
M–3652.
P140031/S085,
M–3845.
FDA–2019–
Dako North America, Inc ........
HeartStart OnSite Defibrillator (Model M5066A), HeartStart
Home Defibrillator (Model M5068A), Primary Battery
(Model M5070A), SMART Pads Cartridges (Adult Model
M5071A) and Infant/Child (Model M5072A).
PD–L1 IHC 22C3 pharmDx .....................................................
6/10/2019
FDA–2019–
MED–EL Corp ........................
MED–EL Cochlear Implant System ........................................
7/19/2019
FDA–2019–
Dako North America, Inc ........
PD–L1 1HC 22C3 pharmDx ....................................................
7/30/2019
FDA–2019–
Edwards Lifesciences LLC .....
Edwards SAPIEN 3 Transcatheter Heart Valve System and
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System.
The TetherTM—Vertebral Body Tethering System ..................
BAROSTIM NEO® System .....................................................
Medtronic CoreValve Evolut R System and Medtronic
CoreValve Evolut PRO System.
Minimally Invasive Deformity Correction (MID–C) System .....
8/16/2019
H190005, FDA–2019–M–3863
P180050, FDA–2019–M–3862
P130021/S058, FDA–2019–
M–3844.
H170001, FDA–2019–M–4007
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Impulse Dynamics (USA), Inc
Fidia Pharma USA, Inc ..........
Channel Medsystems, Inc ......
TherOx, Inc .............................
Intact Vascular, Inc .................
QIAGEN Manchester Ltd .......
BAROnova, Inc .......................
Boston Scientific Corp ............
XVIVO Perfusion, Inc .............
Zimmer Biomet Spine, Inc ......
CVRx, Inc ...............................
Medtronic CoreValve LLC ......
ApiFix, Ltd ..............................
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4/11/2019
4/12/2019
4/16/2019
4/23/2019
4/26/2019
5/2/2019
5/16/2019
5/23/2019
5/24/2019
5/24/2019
5/31/2019
8/16/2019
8/16/2019
8/16/2019
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Federal Register / Vol. 86, No. 55 / Wednesday, March 24, 2021 / Notices
15689
TABLE 1—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS AND SAFETY AND PROBABLE BENEFIT
SUMMARIES FOR APPROVED HDES MADE AVAILABLE FROM OCTOBER 1, 2018, THROUGH DECEMBER 31, 2020—
Continued
PMA No., Docket No.
Applicant
Trade name
P040020/S087, FDA–2019–
M–4153.
Alcon Laboratories, Inc ..........
8/26/2019
P190006, FDA–2019–M–4186
Axonics Modulation Technologies, Inc.
AMO Manufacturing USA,
LLC.
DiaSorin Inc ............................
AcrySof® IQ PanOptix® Trifocal Intraocular Lens (Model
TFNT00) and AcrySof® IQ PanOptix® Toric Trifocal Intraocular Lens (Models TFNT30, TFNT40, TFNT50 and
TFNT60).
Axonics Sacral Neuromodulation System ...............................
iDESIGN® Refractive Studio and STAR S4 IR® Excimer
Laser Systems.
LIAISON XL MUREX HCV Ab LIAISON XL MUREX Control
HCV Ab.
Myriad myChoice® CDx ..........................................................
9/9/2019
10/18/2019
Axonics Sacral Neuromodulation System ...............................
11/13/2019
11/15/2019
P930016/S057, FDA–2019–
M–4238.
P190011, FDA–2019–M–4928
P190014, FDA–2019–M–4978
9/6/2019
P180035, FDA–2019–M–5438
Myriad Genetic Laboratories,
Inc.
Axonics Modulation Technologies, Inc.
CooperVision, Inc ...................
P190008, FDA–2019–M–5534
Medtronic, Inc .........................
P190016, FDA–2019–M–5605
P180047, FDA–2019–M–5683
Tusker Medical, Inc ................
DiaSorin, Inc ...........................
P170019/S006, FDA–2019–
M–5741.
P170038, FDA–2019–M–5857
P180027, FDA–2019–M–5961
P140009/S039, FDA–2020–
M–0097.
P180038, FDA–2020–M–0107
Foundation Medicine, Inc .......
MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact
Lenses for Daily Wear.
IN.PACTTM AV Paclitaxel-coated Percutaneous Transluminal
Angioplasty (PTA) Balloon Catheter.
Tula® System ..........................................................................
LIAISON QuantiFERON—TB Gold Plus, LIAISON Control
QuantiFERON—TB
Gold
Plus
and
LIAISON
QuantiFERON Software.
FoundationOne® CDx .............................................................
Abbott .....................................
MicroVention, Inc ....................
Abbott Medical, Inc .................
CentriMag Circulatory Support System ...................................
Flow Re-Direction Endoluminal Device (FRED®) System ......
Abbott InfinityTM DBS System .................................................
12/6/2019
12/16/2019
1/2/2020
DiaSorin, Inc ...........................
1/2/2020
P190018, FDA–2020–M–0108
Alcon Research, Inc ...............
P170023, FDA–2020–M–0495
P170022, FDA–2020–M–0985
P180039, FDA–2020–M–0984
Contura International A/S .......
ARJ Medical, Inc ....................
DiaSorin Inc ............................
P930014/S126, FDA–2020–
M–0986.
Alcon Laboratories, Inc ..........
P190024, FDA–2020–M–1083
P120006/S031, FDA–2020–
M–1126.
P980033/S050, FDA–2020–
M–1115.
P970051/S172, FDA–2020–
M–1116.
P190025, FDA–2020–M–1175
P140029/S021, FDA–2020–
M–1214.
P190028, FDA–2020–M–1213
P190027, FDA–2020–M–1286
P050010/S020, FDA–2020–
M–1267.
P130008/S039, FDA–2020–
M–1299.
Ventana Medical Systems, Inc
Endologix, Inc .........................
LIAISON® XL MUREX Anti-HBc, LIAISON® XL MUREX
Control Anti-HBc.
ClareonTM Aspheric Hydrophobic Acrylic Intraocular Lens
(IOL) (Model Number: SY60WF); ClareonTM Toric
Aspheric Hydrophobic Acrylic Intraocular Lens (IOL)
(Model Numbers: CNW0T3, CNW0T4, CNW0T5,
CNW0T6, CNW0T7, CNW0T8 and CNW0T9); ClareonTM
Aspheric Hydrophobic Acrylic Intraocular Lens (IOL) with
the AutonoMeTM Pre-loaded Delivery System (Model
Number: CNA0T0); ClareonTM Toric Aspheric Hydrophobic
Acrylic Intraocular Lens (IOL) with the AutonoMeTM Preloaded Delivery System (Model Numbers: CNA0T3,
CNA0T4, CNA0T5, CNA0T6, CNA0T7, CNA0T8 and
CNA0T9).
Bulkamid® Urethral Bulking System .......................................
PyloPlus UBT System .............................................................
LIAISON® XL MUREX Anti-HBs; LIAISON® XL MUREX
Control Anti-HBs; LIAISON® XL MUREX Anti-HBs
Verifiers.
AcrySofTM IQ VivityTM Extended Vision Intraocular Lens
(Model DFT015); AcrySofTM IQ VivityTM Toric Extended
Vision IOLs (DFT315, DFT 415, DFT515); AcrySofTM IQ
VivityTM Extended Vision UV Absorbing IOL (DAT015);
AcrySofTM IQ VivityTM Toric Extended Vision UV Absorbing IOLs (DAT315, DAT415, DAT515).
CINtec® PLUS Cytology ..........................................................
AltoTM Abdominal Stent Graft System ....................................
3/10/2020
3/13/2020
Boston Scientific Corp ............
VENOUS WALLSTENT ...........................................................
3/17/2020
Cochlear Americas .................
Nucleus 24 Cochlear Implant System .....................................
3/17/2020
Abbott Molecular, Inc .............
Q-Med AB, a Galderma affiliate.
Roche Molecular Systems, Inc
Intact Vascular, Inc .................
Centinel Spine, LLC ...............
Alinity m HCV ..........................................................................
Restylane® Kysse ...................................................................
3/23/2020
3/26/2020
cobas HPV for use on the cobas 6800/8800 Systems ...........
Tack Endovascular System® (4F, 1.5–4.5mm) ......................
prodisc® L Total Disc Replacement ........................................
4/3/2020
4/10/2020
4/10/2020
Inspire Medical Systems, Inc
Inspire® Upper Airway Stimulation (UAS) ...............................
4/14/2020
P180046, FDA–2019–M–5393
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12/3/2019
1/7/2020
1/28/2020
2/18/2020
2/21/2020
2/26/2020
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TABLE 1—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS AND SAFETY AND PROBABLE BENEFIT
SUMMARIES FOR APPROVED HDES MADE AVAILABLE FROM OCTOBER 1, 2018, THROUGH DECEMBER 31, 2020—
Continued
PMA No., Docket No.
Applicant
Trade name
P190026, FDA–2020–M–1290
P170019/S013, FDA–2020–
M–1300.
P190015, FDA–2020–M–1311
P170019/S011, FDA–2020–
M–1358.
P160028, FDA–2020–M–1367
QIAGEN GmbH ......................
Foundation Medicine, Inc .......
therascreen® BRAF V600E RGQ PCR Kit .............................
FoundationOne® CDx (F1CDx) ...............................................
4/15/2020
4/17/2020
Bolton Medical Inc ..................
Foundation Medicine, Inc .......
TREO® Abdominal Stent-Graft System ..................................
FoundationOne® CDx (F1CDx) ...............................................
5/4/2020
5/6/2020
Philips Medical Systems, Inc
5/11/2020
P180028, FDA–2020–M–1368
Philips Medical Systems, Inc
P150025/S013, FDA–2020–
M–1410.
P170019/S015, FDA–2020–
M–1420.
P110033/S047, FDA–2020–
M–1527.
P190021, FDA–2020–M–1583
P170019/S016, FDA–2020–
M–1612.
P200014, FDA–2020–M–1600
P100010/S098, FDA–2020–
M–1613.
Dako North America, Inc ........
HeartStart FR3 Defibrillators Models 861388 (Text) and
861389 (ECG Display), Primary Battery (Models
989803150161, 989803150171), Rechargeable Battery
(Model 989803150241), Charger for the Rechargeable
Battery (Model 861394), SmartPads III (Models
989803149981, 989803149991), DP pads (Models
989803158211, 989803158221), and Pediatric Key (Model
989803150031).
HeartStart FRx Defibrillator (861304), Primary Battery
(M5070A), Aviation FRx Battery (989803139301), SMART
Pads II (989803139261), and Infant/Child Key
(989803139311).
PD–L1 IHC 28–8 pharmDx .....................................................
Foundation Medicine, Inc .......
FoundationOne® CDx .............................................................
5/19/2020
Allergan ..................................
´ DERM® VOLUMATM XC ................................................
JUVE
6/12/2020
Mainstay Medical Ltd .............
Foundation Medicine, Inc .......
ReActiv8 Implantable Neurostimulation System .....................
FoundationOne® CDx (F1CDx) ...............................................
6/16/2020
6/16/2020
Roche Molecular Systems, Inc
Medtronic, Inc .........................
cobas® EZH2 Mutation Test ...................................................
Arctic Front AdvanceTM Cardiac Cryoablation Catheter Arctic
Front Advance ProTM Cardiac Cryoablation Catheters
FreezorTM
MAX
Cardiac
Cryoablation
Catheter
CryoConsole Manual Retraction Kit.
WATCHMAN FLX Left Atrial Appendage Closure Device
with Delivery System and WATCHMAN Left Atrial Appendage Closure Device with Delivery System.
VENTANA HER2 Dual ISH DNA Probe Cocktail ...................
Neuroform Atlas® Stent System .............................................
6/18/2020
6/23/2020
Guardant360® CDx .................................................................
KendallTM Multi-Function Defibrillation Electrodes, MediTraceTM Cadence Multi-Function Defibrillation Electrodes,
Physio-Control/Stryker
QUIK–COMBO
Pacing/
Defibrillation/ECG Electrodes.
SYNERGYTM Everolimus-Eluting Platinum Chromium Coronary
Stent
System
(MonorailTM);
SYNERGYTM
Everolimus-Eluting Platinum Chromium Coronary Stent
System (Over-The-WireTM); SYNERGYTM XD EverolimusEluting Platinum Chromium Coronary Stent System (MonorailTM).
FoundationOne Liquid CDx .....................................................
LIAISON® XL MUREX HBeAg, LIAISON® XL MUREX Control HBeAg.
LIAISON® XL MUREX anti-HBe, LIAISON® XL MUREX
Control Anti-HBe.
LIAISON® XL MUREX HBc IgM, LIAISON® XL MUREX
Control HBc IgM.
Alinity m HBV ..........................................................................
LIAISON® XL MUREX HBsAg Qual; LIAISON® MUREX
Control HBsAg Qual; LIAISON® XL MUREX HBsAg Confirmatory Test.
Edwards SAPIEN 3 Transcatheter Heart Valve System with
Edwards Commander Delivery System.
MiniMed 770G System ............................................................
8/7/2020
8/7/2020
P130013/S035, FDA–2020–
M–1715.
Boston Scientific Corp ............
P190031, FDA–2020–M–1724
P180031/S001, FDA–2020–
M–1726.
P200010, FDA–2020–M–1748
P190007, FDA–2020–M–1752
Ventana Medical Systems, Inc
Stryker Neurovascular ............
P150003/S058, FDA–2020–
M–1760.
Boston Scientific Corp ............
P190032, FDA–2020–M–1821
P180048, FDA–2020–M–1783
Foundation Medicine, Inc .......
Diasorin, Inc ...........................
P180049, FDA–2020–M–1822
Diasorin, Inc ...........................
P180045, FDA–2020–M–1828
Diasorin, Inc ...........................
P200013, FDA–2020–M–1830
P190017, FDA–2020–M–1829
Abbott Molecular, Inc .............
Diasorin, Inc ...........................
P200015, FDA–2020–M–1835
Edwards Lifesciences, LLC ....
P160017/S076, FDA–2020–
M–1838.
P140031/S112, FDA–2020–
M–1868.
P200022, FDA–2020–M–1986
P160042/S010, FDA–2020–
M–2021.
Medtronic Minimed, Inc ..........
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Guardant Health, Inc ..............
Cardinal Health .......................
Edwards Lifesciences, LLC ....
Simplify Medical, Inc ..............
Prollenium Medical Technologies, Inc.
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Edwards SAPIEN 3 and SAPIEN 3 Ultra Transcatheter
Heart Valve System.
Simplify® Cervical Artificial Disc ..............................................
Revanesse® Lips+ ..................................................................
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5/15/2020
7/21/2020
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7/30/2020
8/10/2020
8/26/2020
8/29/2020
8/29/2020
8/29/2020
8/29/2020
8/29/2020
8/31/2020
8/31/2020
9/9/2020
9/18/2020
9/21/2020
15691
Federal Register / Vol. 86, No. 55 / Wednesday, March 24, 2021 / Notices
TABLE 1—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS AND SAFETY AND PROBABLE BENEFIT
SUMMARIES FOR APPROVED HDES MADE AVAILABLE FROM OCTOBER 1, 2018, THROUGH DECEMBER 31, 2020—
Continued
PMA No., Docket No.
Applicant
Trade name
H190001, FDA–2020–M–2248
P190030, FDA–2020–M–2288
P200030, FDA–2020–M–2339
HDL Therapeutics, Inc ...........
Theragen, Inc .........................
W. L. Gore and Associates,
Inc.
Plasma Delipidation System (PDS–2TM System) ...................
ActaStim-S Spine Fusion Stimulator .......................................
GORE® EXCLUDER® Conformable AAA Endoprosthesis
(EXCC).
II. Electronic Access
Persons with access to the internet
may obtain the documents at https://
www.fda.gov/MedicalDevices/
ProductsandMedicalProcedures/Device
ApprovalsandClearances/
PMAApprovals/default.htm.
Dated: March 15, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–06052 Filed 3–23–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Office of the Director, National
Institutes of Health; Notice of Meeting
khammond on DSKJM1Z7X2PROD with NOTICES
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the NIH Clinical Center
Research Hospital Board.
The meeting will be held as a virtual
meeting and open to the public.
Individuals who plan to view the virtual
meeting and need special assistance or
other reasonable accommodations to
view the meeting should notify the
Contact Person listed below in advance
of the meeting. The meeting can be
accessed from the NIH Videocast
https://videocast.nih.gov/ and the
CCRHB website https://
ccrhb.od.nih.gov/meetings.html.
Name of Committee: NIH Clinical Center
Research Hospital Board.
Date: April 23, 2021.
Time: 9:00 a.m. to 1:00 p.m.
Agenda: Clinical Center CEO Update,
Patient Safety and Clinical Quality Update,
other business of the Board.
Place: National Institutes of Health,
Building 1, 9000 Rockville Pike, Bethesda,
MD 20892 (Virtual Meeting).
Contact Person: Gretchen Wood, Staff
Assistant, National Institutes of Health,
Office of the Director, One Center Drive,
Building 1, Room 126, Bethesda, MD 20892,
301–496–4272, woodgs@od.nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
VerDate Sep<11>2014
16:30 Mar 23, 2021
Jkt 253001
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.14, Intramural Research
Training Award; 93.22, Clinical Research
Loan Repayment Program for Individuals
from Disadvantaged Backgrounds; 93.232,
Loan Repayment Program for Research
Generally; 93.39, Academic Research
Enhancement Award; 93.936, NIH Acquired
Immunodeficiency Syndrome Research Loan
Repayment Program; 93.187, Undergraduate
Scholarship Program for Individuals from
Disadvantaged Backgrounds, National
Institutes of Health, HHS)
Dated: March 18, 2021.
Patricia B. Hansberger,
Supervisory Program Analyst, Office of
Federal Advisory Committee Policy.
[FR Doc. 2021–06021 Filed 3–23–21; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases;
Amended Notice of Meeting
Notice is hereby given of a change in
the meeting of the National Diabetes and
Digestive and Kidney Diseases Advisory
Council, May 12, 2021, 10:00 a.m. to
May 13, 2021, 01:45 p.m., National
Institutes of Health, Two Democracy
Plaza, 6707 Democracy Boulevard,
Bethesda, MD, 20892 which was
published in the Federal Register on
December 28, 2020, 85 FR 84358.
This notice is being amended to
change the meeting time from 10:00
a.m.–1:15 p.m. on May 12, 2021 to 10:00
a.m.–3:00 p.m. on May 12, 2021. The
meeting is to the public.
Dated: March 18, 2021.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2021–06020 Filed 3–23–21; 8:45 am]
BILLING CODE 4140–01–P
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12/1/2020
12/9/20
12/22/20
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
Docket ID: FEMA–2020–0036; OMB No.
1660–0105]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request; National
Household Survey on Disaster
Preparedness
Federal Emergency
Management Agency, Department of
Homeland Security.
ACTION: 30-Day notice of revision and
request for comments.
AGENCY:
The Federal Emergency
Management Agency (FEMA), as part of
its continuing effort to reduce
paperwork and respondent burden,
invites the general public to take this
opportunity to comment on a revision of
a currently approved information
collection. In accordance with the
Paperwork Reduction Act of 1995, this
notice seeks comments concerning the
charge to FEMA and the Department of
Homeland Security (DHS) to meet
FEMA strategic priorities, and FEMA’s
program management to improve the
public’s knowledge and actions for
preparedness and resilience.
Information from this collection will be
used to track changes in knowledge,
attitudes, and behaviors related to
preparedness in the general public. The
Individual and Community
Preparedness Division analyzes and
uses data collected in FEMA Form 008–
0–15, National Disaster Preparedness
Survey to identify progress and gaps in
individual and community
preparedness to better understand the
motivators and barriers to preparedness
in general and about specific hazards.
The survey measures the public’s
knowledge, attitudes, and behaviors
relative to preparing for a wide range of
hazards.
DATES: Comments must be submitted on
or before April 23, 2021.
ADDRESSES: Written comments and
recommendations for the proposed
SUMMARY:
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]]>Agencies
[Federal Register Volume 86, Number 55 (Wednesday, March 24, 2021)]
[Notices]
[Pages 15686-15691]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-06052]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2018-M-3841, FDA-2018-M-3842, FDA-2018-M-3983, FDA-
2018-M-4033, FDA-2018-M-4205, FDA-2018-M-4580, FDA-2018-M-4582, FDA-
2018-M-4665, FDA-2018-M-4777, FDA-2018-M-4778, FDA-2018-M-4779, FDA-
2018-M-4780, FDA-2018-M-4916, FDA-2019-M-0027, FDA-2019-M-0028, FDA-
2019-M-0505, FDA-2019-M-0645, FDA-2019-M-0802, FDA-2019-M-0885, FDA-
2019-M-0995, FDA-2019-M-1214, FDA-2019-M-1251, FDA-2019-M-1310, FDA-
2019-M-1313, FDA-2019-M-1465, FDA-2019-M-1506, FDA-2019-M-1582, FDA-
2019-M-1763, FDA-2019-M-1848, FDA-2019-M-1979, FDA-2019-M-1998, FDA-
2019-M-2052, FDA-2019-M-2193, FDA-2019-M-2408, FDA-M-2522, FDA-2019-M-
2560, FDA-2019-M-2561, FDA-2019-M-2671, FDA-2019-M-2732, FDA-2019-M-
2753, FDA-2019-M-2782, FDA-2019-M-3309, FDA-2019-M-3513, FDA-2019-M-
3652, FDA-2019-M-3845, FDA-2019-M-3863, FDA-2019-M-3844, FDA-2019-M-
4007, FDA-2019-M-4153, FDA-2019-M-4186, FDA-2019-M-4238, FDA-2019-M-
4928, FDA-2019-M-4978, FDA-2019-M-5393, FDA-2019-M-5438, FDA-2019-M-
5534, FDA-2019-M-5605, FDA-2019-M-5683, FDA-2019-M-5741, FDA-2019-M-
5857, FDA-2019-M-5961, FDA-2020-M-0097, FDA-2020-M-0107, FDA-2020-M-
0108, FDA-2020-M-0495, FDA-2020-M-0985, FDA-2020-M-0984, FDA-2020-M-
0986, FDA-2020-M-1083, FDA-2020-M-1115, FDA-2020-M-1116, FDA-2020-M-
1175, FDA-2020-M-1213, FDA-2020-M-1214, FDA-2020-M-1267, FDA-2020-M-
1286, FDA-2020-M-1290, FDA-2020-M-1299, FDA-2020-M-1300, FDA-2020-M-
1311, FDA-2020-M-1358, FDA-2020-M-1367, FDA-2020-M-1410, FDA-2020-M-
1420, FDA-2020-M-1527, FDA-2020-M-1583, FDA-2020-M-1600, FDA-2020-M-
1612, FDA-2020-M-1613, FDA-2020-M-1715, FDA-2020-M-1724, FDA-2020-M-
1726, FDA-2020-M-1748, FDA-2020-M-1752, FDA-2020-M-1760, FDA-2020-M-
1821, FDA-2020-M-1783, FDA-2020-M-1822, FDA-2020-M-1828, FDA-2020-M-
1830, FDA-2020-M-1829, FDA-2020-M-1835, FDA-2020-M-1838, FDA-2020-M-
1868, FDA-2020-M-1986, FDA-2020-M-2021, FDA-2020-M-2288, FDA-2020-M-
2248, and FDA-2020-M-2339]
Medical Devices; Availability of Safety and Effectiveness
Summaries for Premarket Approval Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is publishing
a list of premarket approval applications (PMAs) that have been
approved from October 1, 2018, through December 31, 2020. This list is
intended to inform the public of the availability of safety and
effectiveness summaries of approved PMAs through the internet and the
Agency's Dockets Management Staff.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket Nos.
FDA-2018-M-3841, FDA-2018-M-3842, FDA-2018-M-3983, FDA-2018-M-4033,
FDA-2018-M-4205, FDA-2018-M-4580, FDA-2018-M-4582, FDA-
[[Page 15687]]
2018-M-4665, FDA-2018-M-4777, FDA-2018-M-4778, FDA-2018-M-4779, FDA-
2018-M-4780, FDA-2018-M-4916, FDA-2019-M-0027, FDA-2019-M-0028, FDA-
2019-M-0505, FDA-2019-M-0645, FDA-2019-M-0802, FDA-2019-M-0885, FDA-
2019-M-0995, FDA-2019-M-1214, FDA-2019-M-1251, FDA-2019-M-1310, FDA-
2019-M-1313, FDA-2019-M-1465, FDA-2019-M-1506, FDA-2019-M-1582, FDA-
2019-M-1763, FDA-2019-M-1848, FDA-2019-M-1979, FDA-2019-M-1998, FDA-
2019-M-2052, FDA-2019-M-2193, FDA-2019-M-2408, FDA-2019-M-2522, FDA-
2019-M-2560, FDA-2019-M-2561, FDA-2019-M-2671, FDA-2019-M-2732, FDA-
2019-M-2753, FDA-2019-M-2782, FDA-2019-M-3309, FDA-2019-M-3513, FDA-
2019-M-3652, FDA-M-3845, FDA-2019-M-3862, FDA-2019-M-3863, FDA-2019-M-
3844, FDA-2019-M-4007, FDA-2019-M-4153, FDA-2019-M-4186, FDA-2019-M-
4238, FDA-2019-M-4928, FDA-2019-M-4978, FDA-2019-M-5393, FDA-2019-M-
5438, FDA-2019-M-5534, FDA-2019-M-5605, FDA-2019-M-5683, FDA-2019-M-
5741, FDA-2019-M-5857, FDA-2019-M-5961, FDA-2020-M-0097, FDA-2020-M-
0107, FDA-2020-M-0108, FDA-2020-M-0495, FDA-2020-M-0985, FDA-2020-M-
0984, FDA-2020-M-0986, FDA-2020-M-1083, FDA-2020-M-1115, FDA-2020-M-
1116, FDA-2020-M-1175, FDA-2020-M-1213, FDA-2020-M-1214, FDA-2020-M-
1267, FDA-2020-M-1286, FDA-2020-M-1290, FDA-2020-M-1299, FDA-2020-M-
1300, FDA-2020-M-1311, FDA-2020-M-1358, FDA-2020-M-1367, FDA-2020-M-
1410, FDA-2020-M-1420, FDA-2020-M-1527, FDA-2020-M-1583, FDA-2020-M-
1600, FDA-2020-M-1612, FDA-2020-M-1613, FDA-2020-M-1715, FDA-2020-M-
1724, FDA-2020-M-1726, FDA-2020-M-1748, FDA-2020-M-1752, FDA-2020-M-
1760, FDA-2020-M-1821, FDA-2020-M-1783, FDA-2020-M-1822, FDA-2020-M-
1828, FDA-2020-M-1830, FDA-2020-M-1829, FDA-2020-M-1835, FDA-2020-M-
1838, FDA-2020-M-1868, FDA-2020-M-1986, FDA-2020-M-2021, FDA-2020-M-
2288, FDA-2020-M-2248, and FDA-2020-M-2339 for ``Medical Devices;
Availability of Safety and Effectiveness Summaries for Premarket
Approval Applications.'' Received comments will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Dharmesh Patel, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2434, Silver Spring, MD 20993-0002, 301-796-3289.
SUPPLEMENTARY INFORMATION:
I. Background
In accordance with section 515(d)(4) and (e)(2) of the Federal
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360e(d)(4) and
(e)(2)), notification of an order approving, denying, or withdrawing
approval of a PMA will continue to include a notice of opportunity to
request review of the order under section 515(g) of the FD&C Act. The
30-day period for requesting reconsideration of an FDA action under
Sec. 10.33(b) (21 CFR 10.33(b)) for notices announcing approval of a
PMA begins on the day the notice is published in the Federal Register.
Section 10.33(b) provides that FDA may, for good cause, extend this 30-
day period. Reconsideration of a denial or withdrawal of approval of a
PMA may be sought only by the applicant; in these cases, the 30-day
period will begin when the applicant is notified by FDA in writing of
its decision.
The regulations provide that FDA publish a list of available safety
and effectiveness summaries of PMA approvals and denials that were
announced. The following is a list of approved PMAs for which summaries
of safety and effectiveness were placed on the internet from October 1,
2018, through December 31, 2020. There were no denial actions during
this period. The list provides the manufacturer's name, the product's
generic name or the trade name, and the approval date.
Table 1--List of Safety and Effectiveness Summaries for Approved PMAs and Safety and Probable Benefit Summaries
for Approved HDEs Made Available From October 1, 2018, Through December 31, 2020
----------------------------------------------------------------------------------------------------------------
PMA No., Docket No. Applicant Trade name Approval date
----------------------------------------------------------------------------------------------------------------
P180003, FDA-2018-M-3841.............. Veryan Medical Ltd...... BioMimics 3D Vascular Stent 10/4/2018
System.
P150040/S003, FDA-2018-M-3842......... Carl Zeiss Meditec, Inc. VisuMax Femtosecond Laser.... 10/4/2018
P160054/S008, FDA-2018-M-3983......... Thoratec Corp........... HeartMate 3 Left Ventricular 10/18/2018
Assist System.
P100040/S036, FDA-2018-M-4033......... Medtronic Vascular...... Valiant NavionTM Thoracic 10/19/2018
Stent Graft System.
P180010, FDA-2018-M-4205.............. W.L. Gore & Associates, GORE Carotid Stent........... 11/1/2018
Inc.
P150002, FDA-2018-M-4580.............. Cordis Corp............. Cordis INCRAFT[supreg] AAA 11/27/2018
Stent Graft System.
[[Page 15688]]
P120016/S024, FDA-2018-M-4582......... Cardiva Medical, Inc.... VASCADE[supreg] MVP Venous 11/27/2018
Vascular Closure System.
P180007, FDA-2018-M-4665.............. Spiration, Inc.......... Spiration[supreg] Valve 12/3/2018
System.
P160034, FDA-2018-M-4672.............. Cardiac Science Corp.... Powerheart[supreg] G3 Pro AED 12/6/2018
P160033, FDA-2018-M-4675.............. Cardiac Science Corp.... Powerheart[supreg] G5 AED, 12/7/2018
Powerheart[supreg] AED G3
Plus, And Powerheart[supreg]
AED G3.
P160043/S012, FDA-2018-M-4777......... Medtronic Vascular...... Resolute OnyxTM Zotarolimus- 12/14/2018
Eluting Coronary Stent
System.
P110013/S088, FDA-2018-M-4778......... Medtronic Vascular...... Resolute Integrity 12/14/2018
Zotarolimus-Eluting Coronary
Stent System.
P100018/S015, FDA-2018-M-4779......... Micro Therapeutics, Inc. PipelineTM Flex Embolization 12/14/2018
d/b/a ev3 Neurovascular. Device.
P150038/S006, FDA-2018-M-4780......... InSightec, Inc.......... Exablate Model 4000 Types 1.0 12/16/2018
and 1.1 System (Exablate
Neuro).
P170018, FDA-2018-M-4916.............. Physio-Control, Inc..... LIFEPAK[supreg] CR2 12/21/2018
Defibrillator.
P170032, FDA-2019-M-0027.............. Sequent Medical, Inc.... Woven EndoBridge (WEB) 12/31/2018
Aneurysm Embolization System.
P180001, FDA-2019-M-0028.............. William Cook Europe ApS. Zenith[supreg] Dissection 12/31/2018
Endovascular System.
P170037, FDA-2019-M-0505.............. OPKO Diagnostics, LLC... Sangia Total PSA Test........ 1/30/2019
P180025, FDA-19M-2526................. Essential Medical, Inc.. MANTATM Vascular Closure 2/1/2019
Device.
P170036, FDA-2019-M-0645.............. Spinal Kinetics LLC..... M6-CTM Artificial Cervical 2/6/2019
Disc.
P160050, FDA-2019-M-0802.............. Intrinsic Therapeutics.. Barricaid[supreg] Anular 2/8/2019
Closure Device (ACD).
P170030, FDA-2019-M-0885.............. Biotronik, Inc.......... Orsiro Sirolimus Eluting 2/22/2019
Coronary Stent System
(Orsiro Stent System).
P170042/S002, FDA-2019-M-0995......... C.R. Bard, Inc.......... COVERATM Vascular Covered 3/1/2019
Stent.
P160002/S009, FDA-2019-M-1310......... Ventana Medical System, VENTANA PD-L1 (SP142) Assay.. 3/8/2019
Inc.
P180037, FDA-2019-M-1214.............. Bard Peripheral VENOVO Venous Stent System... 3/13/2019
Vascular, Inc. (BPV).
P100009/S028, FDA-2019-M-1251......... Abbott Vascular, Inc.... MitraClip NT Clip Delivery 3/14/2019
System; MitraClip NTR/XTR
Clip Delivery System.
P180036, FDA-2019-M-1313.............. Impulse Dynamics (USA), OPTIMIZER Smart System....... 3/21/2019
Inc.
P180040, FDA-2019-M-1465.............. Fidia Pharma USA, Inc... TRILURONTM................... 3/26/2019
P180032, FDA-2019-M-1506.............. Channel Medsystems, Inc. Cerene[supreg] Cryotherapy 3/28/2019
Device.
P170027, FDA-2019-M-1582.............. TherOx, Inc............. TherOx DownStream System..... 4/2/2019
P180034, FDA-2019-M-1763.............. Intact Vascular, Inc.... Tack Endovascular 4/11/2019
System[supreg] (6F).
P180043, FDA-2019-M-1979.............. QIAGEN Manchester Ltd... therascreen[supreg] FGFR RGQ 4/12/2019
RT-PCR Kit.
P180024, FDA-2019-M-1848.............. BAROnova, Inc........... TransPyloric Shuttle/ 4/16/2019
TransPyloric Shuttle
Delivery Device.
P180029, FDA-2019-M-1998.............. Boston Scientific Corp.. LOTUS EdgeTM Valve System.... 4/23/2019
P180014, FDA-2019-M-2052.............. XVIVO Perfusion, Inc.... XVIVO Perfusion System 4/26/2019
(XPSTM) with STEEN
SolutionTM Perfusate.
P180013, FDA-2019-M-2193.............. Boston Scientific Corp.. VICI VENOUS STENT[supreg] 5/2/2019
System.
P180031, FDA-2019-M-2408.............. Stryker Neurovascular... Neuroform Atlas[supreg] Stent 5/16/2019
System.
H180002, FDA-2019-M-2522.............. Novocure, Ltd........... NovoTTFTM-100L System........ 5/23/2019
P190001, FDA-2019-M-2560.............. QIAGEN GmbH............. therascreen PIK3CA RGQ PCR 5/24/2019
Kit.
P190004, FDA-2019-M-2561.............. QIAGEN GmbH............. therascreen PIK3CA RGQ PCR 5/24/2019
Kit.
P160013/S002, FDA-2019-M-2671......... TransMedics, Inc........ Organ Care System (OCSTM) 5/31/2019
Lung System.
P160036, FDA-2019-M-2732.............. DT MedTech, LLC......... Hintermann Series H3TM Total 6/4/2019
Ankle Replacement System.
P160048/S006, FDA-2019-M-2753......... Senseonics, Inc......... Eversense Continuous Glucose 6/6/2019
Monitoring System.
P160029, FDA-2019-M-2782.............. Philips Medical Systems, HeartStart OnSite 6/6/2019
Inc. Defibrillator (Model
M5066A), HeartStart Home
Defibrillator (Model
M5068A), Primary Battery
(Model M5070A), SMART Pads
Cartridges (Adult Model
M5071A) and Infant/Child
(Model M5072A).
P150013/S014, FDA-2019-M-3309......... Dako North America, Inc. PD-L1 IHC 22C3 pharmDx....... 6/10/2019
P000025/S104, FDA-2019-M-3513......... MED-EL Corp............. MED-EL Cochlear Implant 7/19/2019
System.
P150013/S016, FDA-2019-M-3652......... Dako North America, Inc. PD-L1 1HC 22C3 pharmDx....... 7/30/2019
P140031/S085, FDA-2019-M-3845......... Edwards Lifesciences LLC Edwards SAPIEN 3 8/16/2019
Transcatheter Heart Valve
System and Edwards SAPIEN 3
Ultra Transcatheter Heart
Valve System.
H190005, FDA-2019-M-3863.............. Zimmer Biomet Spine, Inc The TetherTM--Vertebral Body 8/16/2019
Tethering System.
P180050, FDA-2019-M-3862.............. CVRx, Inc............... BAROSTIM NEO[supreg] System.. 8/16/2019
P130021/S058, FDA-2019-M-3844......... Medtronic CoreValve LLC. Medtronic CoreValve Evolut R 8/16/2019
System and Medtronic
CoreValve Evolut PRO System.
H170001, FDA-2019-M-4007.............. ApiFix, Ltd............. Minimally Invasive Deformity 8/23/19
Correction (MID-C) System.
[[Page 15689]]
P040020/S087, FDA-2019-M-4153......... Alcon Laboratories, Inc. AcrySof[supreg] IQ 8/26/2019
PanOptix[supreg] Trifocal
Intraocular Lens (Model
TFNT00) and AcrySof[supreg]
IQ PanOptix[supreg] Toric
Trifocal Intraocular Lens
(Models TFNT30, TFNT40,
TFNT50 and TFNT60).
P190006, FDA-2019-M-4186.............. Axonics Modulation Axonics Sacral 9/6/2019
Technologies, Inc. Neuromodulation System.
P930016/S057, FDA-2019-M-4238......... AMO Manufacturing USA, iDESIGN[supreg] Refractive 9/9/2019
LLC. Studio and STAR S4
IR[supreg] Excimer Laser
Systems.
P190011, FDA-2019-M-4928.............. DiaSorin Inc............ LIAISON XL MUREX HCV Ab 10/18/2019
LIAISON XL MUREX Control HCV
Ab.
P190014, FDA-2019-M-4978.............. Myriad Genetic Myriad myChoice[supreg] CDx.. 10/23/2019
Laboratories, Inc.
P180046, FDA-2019-M-5393.............. Axonics Modulation Axonics Sacral 11/13/2019
Technologies, Inc. Neuromodulation System.
P180035, FDA-2019-M-5438.............. CooperVision, Inc....... MiSight 1 Day (omafilcon A) 11/15/2019
Soft (Hydrophilic) Contact
Lenses for Daily Wear.
P190008, FDA-2019-M-5534.............. Medtronic, Inc.......... IN.PACTTM AV Paclitaxel- 11/21/2019
coated Percutaneous
Transluminal Angioplasty
(PTA) Balloon Catheter.
P190016, FDA-2019-M-5605.............. Tusker Medical, Inc..... Tula[supreg] System.......... 11/25/2019
P180047, FDA-2019-M-5683.............. DiaSorin, Inc........... LIAISON QuantiFERON--TB Gold 11/26/2019
Plus, LIAISON Control
QuantiFERON--TB Gold Plus
and LIAISON QuantiFERON
Software.
P170019/S006, FDA-2019-M-5741......... Foundation Medicine, Inc FoundationOne[supreg] CDx.... 12/3/2019
P170038, FDA-2019-M-5857.............. Abbott.................. CentriMag Circulatory Support 12/6/2019
System.
P180027, FDA-2019-M-5961.............. MicroVention, Inc....... Flow Re-Direction Endoluminal 12/16/2019
Device (FRED[supreg]) System.
P140009/S039, FDA-2020-M-0097......... Abbott Medical, Inc..... Abbott InfinityTM DBS System. 1/2/2020
P180038, FDA-2020-M-0107.............. DiaSorin, Inc........... LIAISON[supreg] XL MUREX Anti- 1/2/2020
HBc, LIAISON[supreg] XL
MUREX Control Anti-HBc.
P190018, FDA-2020-M-0108.............. Alcon Research, Inc..... ClareonTM Aspheric 1/7/2020
Hydrophobic Acrylic
Intraocular Lens (IOL)
(Model Number: SY60WF);
ClareonTM Toric Aspheric
Hydrophobic Acrylic
Intraocular Lens (IOL)
(Model Numbers: CNW0T3,
CNW0T4, CNW0T5, CNW0T6,
CNW0T7, CNW0T8 and CNW0T9);
ClareonTM Aspheric
Hydrophobic Acrylic
Intraocular Lens (IOL) with
the AutonoMeTM Pre-loaded
Delivery System (Model
Number: CNA0T0); ClareonTM
Toric Aspheric Hydrophobic
Acrylic Intraocular Lens
(IOL) with the AutonoMeTM
Pre-loaded Delivery System
(Model Numbers: CNA0T3,
CNA0T4, CNA0T5, CNA0T6,
CNA0T7, CNA0T8 and CNA0T9).
P170023, FDA-2020-M-0495.............. Contura International A/ Bulkamid[supreg] Urethral 1/28/2020
S. Bulking System.
P170022, FDA-2020-M-0985.............. ARJ Medical, Inc........ PyloPlus UBT System.......... 2/18/2020
P180039, FDA-2020-M-0984.............. DiaSorin Inc............ LIAISON[supreg] XL MUREX Anti- 2/21/2020
HBs; LIAISON[supreg] XL
MUREX Control Anti-HBs;
LIAISON[supreg] XL MUREX
Anti-HBs Verifiers.
P930014/S126, FDA-2020-M-0986......... Alcon Laboratories, Inc. AcrySofTM IQ VivityTM 2/26/2020
Extended Vision Intraocular
Lens (Model DFT015);
AcrySofTM IQ VivityTM Toric
Extended Vision IOLs
(DFT315, DFT 415, DFT515);
AcrySofTM IQ VivityTM
Extended Vision UV Absorbing
IOL (DAT015); AcrySofTM IQ
VivityTM Toric Extended
Vision UV Absorbing IOLs
(DAT315, DAT415, DAT515).
P190024, FDA-2020-M-1083.............. Ventana Medical Systems, CINtec[supreg] PLUS Cytology. 3/10/2020
Inc.
P120006/S031, FDA-2020-M-1126......... Endologix, Inc.......... AltoTM Abdominal Stent Graft 3/13/2020
System.
P980033/S050, FDA-2020-M-1115......... Boston Scientific Corp.. VENOUS WALLSTENT............. 3/17/2020
P970051/S172, FDA-2020-M-1116......... Cochlear Americas....... Nucleus 24 Cochlear Implant 3/17/2020
System.
P190025, FDA-2020-M-1175.............. Abbott Molecular, Inc... Alinity m HCV................ 3/23/2020
P140029/S021, FDA-2020-M-1214......... Q-Med AB, a Galderma Restylane[supreg] Kysse...... 3/26/2020
affiliate.
P190028, FDA-2020-M-1213.............. Roche Molecular Systems, cobas HPV for use on the 4/3/2020
Inc. cobas 6800/8800 Systems.
P190027, FDA-2020-M-1286.............. Intact Vascular, Inc.... Tack Endovascular 4/10/2020
System[supreg] (4F, 1.5-
4.5mm).
P050010/S020, FDA-2020-M-1267......... Centinel Spine, LLC..... prodisc[supreg] L Total Disc 4/10/2020
Replacement.
P130008/S039, FDA-2020-M-1299......... Inspire Medical Systems, Inspire[supreg] Upper Airway 4/14/2020
Inc. Stimulation (UAS).
[[Page 15690]]
P190026, FDA-2020-M-1290.............. QIAGEN GmbH............. therascreen[supreg] BRAF 4/15/2020
V600E RGQ PCR Kit.
P170019/S013, FDA-2020-M-1300......... Foundation Medicine, Inc FoundationOne[supreg] CDx 4/17/2020
(F1CDx).
P190015, FDA-2020-M-1311.............. Bolton Medical Inc...... TREO[supreg] Abdominal Stent- 5/4/2020
Graft System.
P170019/S011, FDA-2020-M-1358......... Foundation Medicine, Inc FoundationOne[supreg] CDx 5/6/2020
(F1CDx).
P160028, FDA-2020-M-1367.............. Philips Medical Systems, HeartStart FR3 Defibrillators 5/11/2020
Inc. Models 861388 (Text) and
861389 (ECG Display),
Primary Battery (Models
989803150161, 989803150171),
Rechargeable Battery (Model
989803150241), Charger for
the Rechargeable Battery
(Model 861394), SmartPads
III (Models 989803149981,
989803149991), DP pads
(Models 989803158211,
989803158221), and Pediatric
Key (Model 989803150031).
P180028, FDA-2020-M-1368.............. Philips Medical Systems, HeartStart FRx Defibrillator 5/11/2020
Inc. (861304), Primary Battery
(M5070A), Aviation FRx
Battery (989803139301),
SMART Pads II
(989803139261), and Infant/
Child Key (989803139311).
P150025/S013, FDA-2020-M-1410......... Dako North America, Inc. PD-L1 IHC 28-8 pharmDx....... 5/15/2020
P170019/S015, FDA-2020-M-1420......... Foundation Medicine, Inc FoundationOne[supreg] CDx.... 5/19/2020
P110033/S047, FDA-2020-M-1527......... Allergan................ JUV[Eacute]DERM[supreg] 6/12/2020
VOLUMATM XC.
P190021, FDA-2020-M-1583.............. Mainstay Medical Ltd.... ReActiv8 Implantable 6/16/2020
Neurostimulation System.
P170019/S016, FDA-2020-M-1612......... Foundation Medicine, Inc FoundationOne[supreg] CDx 6/16/2020
(F1CDx).
P200014, FDA-2020-M-1600.............. Roche Molecular Systems, cobas[supreg] EZH2 Mutation 6/18/2020
Inc. Test.
P100010/S098, FDA-2020-M-1613......... Medtronic, Inc.......... Arctic Front AdvanceTM 6/23/2020
Cardiac Cryoablation
Catheter Arctic Front
Advance ProTM Cardiac
Cryoablation Catheters
FreezorTM MAX Cardiac
Cryoablation Catheter
CryoConsole Manual
Retraction Kit.
P130013/S035, FDA-2020-M-1715......... Boston Scientific Corp.. WATCHMAN FLX Left Atrial 7/21/2020
Appendage Closure Device
with Delivery System and
WATCHMAN Left Atrial
Appendage Closure Device
with Delivery System.
P190031, FDA-2020-M-1724.............. Ventana Medical Systems, VENTANA HER2 Dual ISH DNA 7/28/2020
Inc. Probe Cocktail.
P180031/S001, FDA-2020-M-1726......... Stryker Neurovascular... Neuroform Atlas[supreg] Stent 7/30/2020
System.
P200010, FDA-2020-M-1748.............. Guardant Health, Inc.... Guardant360[supreg] CDx...... 8/7/2020
P190007, FDA-2020-M-1752.............. Cardinal Health......... KendallTM Multi-Function 8/7/2020
Defibrillation Electrodes,
Medi-TraceTM Cadence Multi-
Function Defibrillation
Electrodes, Physio-Control/
Stryker QUIK-COMBO Pacing/
Defibrillation/ECG
Electrodes.
P150003/S058, FDA-2020-M-1760......... Boston Scientific Corp.. SYNERGYTM Everolimus-Eluting 8/10/2020
Platinum Chromium Coronary
Stent System (MonorailTM);
SYNERGYTM Everolimus-Eluting
Platinum Chromium Coronary
Stent System (Over-The-
WireTM); SYNERGYTM XD
Everolimus-Eluting Platinum
Chromium Coronary Stent
System (MonorailTM).
P190032, FDA-2020-M-1821.............. Foundation Medicine, Inc FoundationOne Liquid CDx..... 8/26/2020
P180048, FDA-2020-M-1783.............. Diasorin, Inc........... LIAISON[supreg] XL MUREX 8/29/2020
HBeAg, LIAISON[supreg] XL
MUREX Control HBeAg.
P180049, FDA-2020-M-1822.............. Diasorin, Inc........... LIAISON[supreg] XL MUREX anti- 8/29/2020
HBe, LIAISON[supreg] XL
MUREX Control Anti-HBe.
P180045, FDA-2020-M-1828.............. Diasorin, Inc........... LIAISON[supreg] XL MUREX HBc 8/29/2020
IgM, LIAISON[supreg] XL
MUREX Control HBc IgM.
P200013, FDA-2020-M-1830.............. Abbott Molecular, Inc... Alinity m HBV................ 8/29/2020
P190017, FDA-2020-M-1829.............. Diasorin, Inc........... LIAISON[supreg] XL MUREX 8/29/2020
HBsAg Qual; LIAISON[supreg]
MUREX Control HBsAg Qual;
LIAISON[supreg] XL MUREX
HBsAg Confirmatory Test.
P200015, FDA-2020-M-1835.............. Edwards Lifesciences, Edwards SAPIEN 3 8/31/2020
LLC. Transcatheter Heart Valve
System with Edwards
Commander Delivery System.
P160017/S076, FDA-2020-M-1838......... Medtronic Minimed, Inc.. MiniMed 770G System.......... 8/31/2020
P140031/S112, FDA-2020-M-1868......... Edwards Lifesciences, Edwards SAPIEN 3 and SAPIEN 3 9/9/2020
LLC. Ultra Transcatheter Heart
Valve System.
P200022, FDA-2020-M-1986.............. Simplify Medical, Inc... Simplify[supreg] Cervical 9/18/2020
Artificial Disc.
P160042/S010, FDA-2020-M-2021......... Prollenium Medical Revanesse[supreg] Lips+...... 9/21/2020
Technologies, Inc.
[[Page 15691]]
H190001, FDA-2020-M-2248.............. HDL Therapeutics, Inc... Plasma Delipidation System 12/1/2020
(PDS-2TM System).
P190030, FDA-2020-M-2288.............. Theragen, Inc........... ActaStim-S Spine Fusion 12/9/20
Stimulator.
P200030, FDA-2020-M-2339.............. W. L. Gore and GORE[supreg] EXCLUDER[supreg] 12/22/20
Associates, Inc. Conformable AAA
Endoprosthesis (EXCC).
----------------------------------------------------------------------------------------------------------------
II. Electronic Access
Persons with access to the internet may obtain the documents at
https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/PMAApprovals/default.htm.
Dated: March 15, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-06052 Filed 3-23-21; 8:45 am]
BILLING CODE 4164-01-P
