Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications, 57730-57732 [2018-25071]
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Federal Register / Vol. 83, No. 222 / Friday, November 16, 2018 / Notices
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[FR Doc. 2018–25053 Filed 11–15–18; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
amozie on DSK3GDR082PROD with NOTICES
[Docket Nos. FDA–2017–M–6970, FDA–
2017–M–6971, FDA–2017–M–6983, FDA–
2017–M–6984, FDA–2017–M–7004, FDA–
2018–M–0411, FDA–2018–M–0528, FDA–
2018–M–0620, FDA–2018–M–0736, FDA–
2018–M–0737, FDA–2018–M–00–0738, FDA–
2018–M–0792, FDA–2018–M–1371, FDA–
2018–M–1215, FDA–2018–M–1237, FDA–
2018–M–1372, FDA–2018–M–1446, FDA–
2018–M–1447, FDA–2018–M–1580, FDA–
2018–M–1581, FDA–2018–M–1634, FDA–
2018–M–1727, FDA–2018–M–1791, FDA–
2018–M–1753, FDA–2018–M–1970, FDA–
2018–M–2118, FDA–2018–M–2119, FDA–
2018–M–2237, FDA–2018–M–2269, FDA–
2018–M–2335, FDA–2018–M–2460, FDA–
2018–M–2461, FDA–2018–M–2462, FDA–
2018–M–2463, FDA–2018–M–2571, FDA–
2018–M–2883, FDA–2018–M–2884, FDA–
2018–M–2885, FDA–2018–M–2886, FDA–
2018–M–2887, FDA–2018–M–2983, FDA–
2018–M–3131, FDA–2018–M–3153, FDA–
2018–M–3212, FDA–2018–M–3503, FDA–
2018–M–3505, and FDA–2018–M–3548]
Medical Devices; Availability of Safety
and Effectiveness Summaries for
Premarket Approval Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
VerDate Sep<11>2014
17:19 Nov 15, 2018
Jkt 247001
The Food and Drug
Administration (FDA) is publishing a
list of premarket approval applications
(PMAs) and humanitarian device
exemption applications (HDEs), that
have been approved. 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–
2017–M–6970, FDA–2017–M–6971,
FDA–2017–M–6983, FDA–2017–M–
6984, FDA–2017–M–7004, FDA–2018–
M–0411, FDA–2018–M–0528, FDA–
2018–M–0620, FDA–2018–M–0736,
FDA–2018–M–0737, FDA–2018–M–00–
PO 00000
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0738, FDA–2018–M–0792, FDA–2018–
M–1371, FDA–2018–M–1215, FDA–
2018–M–1237, FDA–2018–M–1372,
FDA–2018–M–1446, FDA–2018–M–
1447, FDA–2018–M–1580, FDA–2018–
M–1581, FDA–2018–M–1634, FDA–
2018–M–1727, FDA–2018–M–1791,
FDA–2018–M–1753, FDA–2018–M–
1970, FDA–2018–M–2118, FDA–2018–
M–2119, FDA–2018–M–2237, FDA–
2018–M–2269, FDA–2018–M–2335,
FDA–2018–M–2460, FDA–2018–M–
2461, FDA–2018–M–2462, FDA–2018–
M–2463, FDA–2018–M–2571, FDA–
2018–M–2883, FDA–2018–M–2884,
FDA–2018–M–2885, FDA–2018–M–
2886, FDA–2018–M–2887, FDA–2018–
M–2983, FDA–2018–M–3131, FDA–
2018–M–3153, FDA–2018–M–3212,
FDA–2018–M–3503, FDA–2018–M–
3505, and FDA–2018–M–3548 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.
• 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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf .
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Federal Register / Vol. 83, No. 222 / Friday, November 16, 2018 / Notices
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.
FOR FURTHER INFORMATION CONTACT:
Joshua Nipper, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1650, Silver Spring,
MD 20993–0002, 301–796–6524.
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 placed on the
internet. 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
57731
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 during that quarter. The
following is a list of approved PMAs for
which summaries of safety and
effectiveness were placed on the
internet from January 1, 2018, through
September 18, 2018. 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 JANUARY 1, 2018, THROUGH SEPTEMBER 18, 2018
amozie on DSK3GDR082PROD with NOTICES
PMA No., Docket No.
Applicant
Trade name
Approval date
IntellaNavTM
Open-Irrigated Ablation Catheter and
Open-Irrigated Ablation Catheter.
PREVELEAK Surgical Sealant ....................................................................
12/21/2017
P150005/S014, FDA–2017–M–
6970.
P100030/S008, FDA–2017–M–
6971.
P160012, FDA–2017–M–6983 ..
Physio-Control, Inc ..............................
P140032, FDA–2017–M–6984 ..
P160022, FDA–2017–M–7004 ..
Medtronic, Inc .....................................
ZOLL Medical Corp .............................
P170025, FDA–2018–M–0411 ..
P160032, FDA–2018–M–0528 ..
Hologic, Inc .........................................
Defibtech, LLC ....................................
P140003/S018, FDA–2018–M–
0620.
P160037, FDA–2018–M–0736 ..
P150001/S021, FDA–2018–M–
0737.
P160017/S017, FDA–2018–M–
0738.
P960043/S097, FDA–2018–M–
0792.
P160007, FDA–2018–M–1371 ..
H170002, FDA–2018–M–1215 ..
P160013, FDA–2018–M–1237 ..
P050006/S060, FDA–2018–M–
1372.
P160018/S001, FDA–2018–M–
1446.
P150009, FDA–2018–M–1447 ..
P160052, FDA–2018–M–1581 ..
P950039/S036, FDA–2018–M–
1580.
P140010/S037, FDA–2018–M–
1634.
P960009/S219, FDA–2018–M–
1727.
P170035, FDA–2018–M–1791 ..
P170016, FDA–2018–M–1753 ..
P040024/S099, FDA–2018–M–
1970.
P170013, FDA–2018–M–2118 ..
P170039, FDA–2018–M–2119 ..
P910056/S027, FDA–2018–M–
2237.
P150013/S009, FDA–2018–M–
2269.
P100006/S005, FDA–2018–M–
2335.
P170043, FDA–2018–M–2460 ..
Abiomed, Inc .......................................
LIFEPAK
Plus Defibrillator, LIFEPAK
Defibrillator and
CHARGE–PAK® Battery Charger.
®
Implantable System for Remodulin ...........................................................
X Series®, R Series®, AED Pro®, and AED 3TM BLS® Professional
Defibrillators, Pro-Padz Radiotransparent Electrode, SurePowerTM Battery Pack, SurePower IITM Battery Pack, AED Pro® Non-Rechargeable
Lithium Battery Pack, AED 3TM Battery Pack, SurePowerTM Charger,
and SurePowerTM Single Bay Charger.
Aptima® HBV Quant Assay .........................................................................
Lifeline/ReviveR DDU–100, Lifeline/ReviveR AUTO DDU–120, Lifeline/
ReviveR VIEW DDU–2300, Lifeline/ReviveR VIEW AUTO DDU–2200,
Lifeline/ReviveR ECG DDU–2450, and Lifeline/ReviveR ECG+ DDU–
2475 Automated External Defibrillators.
Impella Ventricular Support Systems ..........................................................
Becton, Dickinson and Co ..................
Medtronic MiniMed, Inc .......................
BD Onclarity HPV Assay .............................................................................
MiniMed 630G System ................................................................................
2/12/2018
2/13/2018
Medtronic MiniMed, Inc .......................
MiniMed 670G System ................................................................................
2/13/2018
Abbott Vascular ...................................
Perclose ProGlide® Suture-Mediated Closure System ...............................
2/16/2018
Medtronic MiniMed, Inc .......................
Kaneka Pharma America LLC ............
TransMedics, Inc .................................
W.L. Gore & Associates, Inc ..............
Guardian Connect System ..........................................................................
LIPOSORBER® LA–15 System ..................................................................
Organ Care System (OCSTM) Lung System ...............................................
GORE® CARDIOFORM Septal Occluder ...................................................
3/8/2018
3/20/2018
3/22/2018
3/30/2018
Foundation Medicine, Inc ....................
FoundationFocusTM CDx BRCA LOH .........................................................
4/6/2018
Angel Medical Systems, Inc ...............
Parsagen Diagnostics, Inc ..................
Hologic, Inc .........................................
AngelMed Guardian System .......................................................................
PartoSure Test ............................................................................................
ThinPrep Integrated Imager ........................................................................
4/9/2018
4/11/2018
4/18/2018
Medtronic Vascular, Inc ......................
4/19/2018
Medtronic, Inc .....................................
IN.PACTTM AdmiralTM Paclitaxel-Coated Percutaneous Transluminal
Angioplasty (PTA) Balloon Catheter.
Medtronic DBS System for Epilepsy ...........................................................
4/27/2018
Bausch + Lomb, Inc ............................
Teva Pharmaceuticals USA, Inc .........
Galderma Laboratories, LP .................
Bausch + Lomb ULTRA (samfilcon A) Contact Lenses ..............................
SYNOJOYNTTM ...........................................................................................
Restylane® Lyft with Lidocaine ...................................................................
4/30/2018
5/8/2018
5/18/2018
MicroVention, Inc ................................
Clinical Research Consultants, Inc .....
Bausch + Lomb, Inc ............................
5/30/2018
5/30/2018
6/8/2018
Dako North America, Inc ....................
Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr ................
CustomFlexTM Artificial Iris ..........................................................................
enVista® One-Piece Hydrophobic Acrylic Toric Intraocular Lens (Model
MX60T).
PD–L1 IHC 22C3 pharmDx .........................................................................
BioMimetic Therapeutics, LLC ............
AUGMENT® Injectable ................................................................................
6/12/2018
Glaukos Corp ......................................
iStent inject Trabecular Micro-Bypass System (Model G2–M–IS) ..............
6/21/2018
VerDate Sep<11>2014
Boston Scientific .................................
Blazer®
Mallinckrodt Pharma IP Trading DAC
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12/21/2017
12/21/2017
12/22/2017
12/27/2017
1/23/2018
2/1/2018
2/7/2018
6/12/2018
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Federal Register / Vol. 83, No. 222 / Friday, November 16, 2018 / Notices
TABLE 1—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS AND SAFETY AND PROBABLE BENEFIT
SUMMARIES FOR APPROVED HDES MADE AVAILABLE FROM JANUARY 1, 2018, THROUGH SEPTEMBER 18, 2018—
Continued
PMA No., Docket No.
Applicant
Trade name
P160017/S031, FDA–2018–M–
2461.
P160048, FDA–2018–M–2463 ..
P180008, FDA–2018–M–2462 ..
P180002, FDA–2018–M–2571 ..
P160026, FDA–2018–M–2883 ..
Medtronic MiniMed, Inc .......................
MiniMed 670G System ................................................................................
6/21/2018
Senseonics, Inc ...................................
Tandem Diabetes Care, Inc ................
Pulmonx Corp .....................................
Physio-Control, Inc ..............................
6/21/2018
6/21/2018
6/29/2018
7/2/2018
Stryker Neurovascular ........................
Abbott Molecular, Inc ..........................
Abbott Diabetes Care Inc ...................
Eversense Continuous Glucose Monitoring System ...................................
t:slim X2 Insulin Pump with Basal-IQ Technology ......................................
Zephyr® Endobronchial Valve System ........................................................
LIFEPAK® 1000 Defibrillator, LIFEPAK® 1000 Defibrillator Lithium-Ion
Rechargeable Battery, LIFEPAK® 1000 Defibrillator Non-Rechargeable
Battery, LIFEPAK® 20 Defibrillator/Monitor (Refurbished), LIFEPAK®
20e Defibrillator/Monitor, LIFEPAK® 15 Monitor/Defibrillator, LIFEPAK®
Lithium-ion Rechargeable Battery (for use with the LIFEPAK® 15 Monitor/Defibrillator).
Surpass Streamline Flow Diverter ...............................................................
Abbott RealTime IDH1 ................................................................................
FreeStyle Libre 14 Day Flash Glucose Monitoring System ........................
7/13/2018
7/20/2018
7/23/2018
Endomagnetics Ltd .............................
C.R. Bard, Inc .....................................
Edwards Lifesciences LLC .................
MagtraceTM and Sentimag® Magnetic Localization System .......................
COVERATM Vascular Covered Stent ..........................................................
Edwards Pericardial Mitral Bioprosthesis, Model 11000M ..........................
7/24/2018
7/30/2018
8/9/2018
Ivantis, Inc ...........................................
Dako North America, Inc ....................
Hydrus® Microstent .....................................................................................
PD–L1 IHC 22C3 pharmDx .........................................................................
8/10/2018
8/16/2018
STAAR Surgical Co ............................
Visian® TORIC ICL (Implantable Collamer® Lens) .....................................
9/13/2018
BIOTRONIK, Inc .................................
Boston Scientific Corp ........................
PK Papyrus Covered Coronary Stent System ............................................
ELUVIATM Drug-Eluting Vascular Stent System .........................................
9/14/2018
9/18/2018
P170024, FDA–2018–M–2884 ..
P170041, FDA–2018–M–2885 ..
P160030/S017, FDA–2018–M–
2886.
P160053, FDA–2018–M–2887 ..
P170042, FDA–2018–M–2983 ..
P150048/S012, FDA–2018–M–
3131.
P170034, FDA–2018–M–3153 ..
P150013/S011, FDA–2018–M–
3212.
P030016/S001, FDA–2018–M–
3503.
H170004, FDA–2018–M–3505 ..
P180011, FDA–2018–M–3548 ..
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: November 13, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–25071 Filed 11–15–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–4002]
Electronic Submission of Adverse
Event Reports to the Food and Drug
Administration Adverse Event
Reporting System Using International
Council for Harmonisation E2B(R3)
Standards; Public Meetings; Request
for Comments
AGENCY:
Food and Drug Administration,
Notice of public meetings;
request for comments.
ACTION:
amozie on DSK3GDR082PROD with NOTICES
The first public meeting will be
held on January 25, 2019, from 9 a.m.
to 4 p.m. The second public meeting
will be held on July 17, 2019, from 9
a.m. to 4 p.m. The third public meeting
will be held on February 19, 2020 from
9 a.m. to 4 p.m. Submit either electronic
or written comments on these public
meetings by February 25, 2019, for the
first public meeting; by August 16, 2019,
DATES:
HHS.
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing three public meetings
entitled ‘‘Electronic Submission of
Adverse Event Reports to FDA Adverse
Event Reporting System (FAERS) Using
SUMMARY:
VerDate Sep<11>2014
International Council for Harmonisation
(ICH) E2B(R3) Standards.’’ The purpose
of these public meetings is to provide
the pharmaceutical industry and other
interested parties with information on
the plans, progress, and technical
specifications to upgrade electronic
submission standards for drug,
biological, and drug/biologic-led
combination products for the premarket
and postmarket safety surveillance
programs managed by the Center for
Drug Evaluation and Research (CDER)
and the Center for Biologics Evaluation
and Research (CBER). These meetings
will focus on enhancements to
electronic submission of Individual
Case Safety Reports (ICSRs) in FAERS
using ICH E2B(R3) standards.
FDA is seeking input from
stakeholders as it fulfills its
commitment to implement ICH E2B(R3)
standards by holding three public
meetings. FDA will use the information
provided by the public to inform the
enhancements to FAERS required for
the implementation of ICH E2B(R3)
standards and relevant regional
variations.
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Approval date
for the second public meeting, and by
March 20, 2020, for the third public
meeting. See the SUPPLEMENTARY
INFORMATION section for registration
dates and information.
ADDRESSES: Each public meeting will be
held at the FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503, Section A), Silver Spring, MD
20993–0002. Entrance for the public
meeting participants (non-FDA
employees) is through Building 1, where
routine security check procedures will
be performed. For parking and security
information, please refer to https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
default.htm.
You may submit comments as
follows. Please note that late, untimely
filed comments will not be considered.
For timely consideration, we request
that electronic comments be submitted
before or within 30 days after each
public meeting (i.e., comments
submitted by or before February 25,
2019, for the first public meeting;
August 16, 2019, for the second public
meeting; and March 20, 2020, for the
third public meeting. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
February 25, 2019; August 16, 2019; and
March 20, 2020, after the first, second,
and the third meeting, respectively.
Comments received by mail/hand
E:\FR\FM\16NON1.SGM
16NON1
]]>Agencies
[Federal Register Volume 83, Number 222 (Friday, November 16, 2018)]
[Notices]
[Pages 57730-57732]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-25071]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2017-M-6970, FDA-2017-M-6971, FDA-2017-M-6983, FDA-
2017-M-6984, FDA-2017-M-7004, FDA-2018-M-0411, FDA-2018-M-0528, FDA-
2018-M-0620, FDA-2018-M-0736, FDA-2018-M-0737, FDA-2018-M-00-0738, FDA-
2018-M-0792, FDA-2018-M-1371, FDA-2018-M-1215, FDA-2018-M-1237, FDA-
2018-M-1372, FDA-2018-M-1446, FDA-2018-M-1447, FDA-2018-M-1580, FDA-
2018-M-1581, FDA-2018-M-1634, FDA-2018-M-1727, FDA-2018-M-1791, FDA-
2018-M-1753, FDA-2018-M-1970, FDA-2018-M-2118, FDA-2018-M-2119, FDA-
2018-M-2237, FDA-2018-M-2269, FDA-2018-M-2335, FDA-2018-M-2460, FDA-
2018-M-2461, FDA-2018-M-2462, FDA-2018-M-2463, FDA-2018-M-2571, FDA-
2018-M-2883, FDA-2018-M-2884, FDA-2018-M-2885, FDA-2018-M-2886, FDA-
2018-M-2887, FDA-2018-M-2983, FDA-2018-M-3131, FDA-2018-M-3153, FDA-
2018-M-3212, FDA-2018-M-3503, FDA-2018-M-3505, and FDA-2018-M-3548]
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) is publishing a list of
premarket approval applications (PMAs) and humanitarian device
exemption applications (HDEs), that have been approved. 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-2017-M-6970, FDA-2017-M-6971, FDA-2017-M-6983, FDA-2017-M-6984,
FDA-2017-M-7004, FDA-2018-M-0411, FDA-2018-M-0528, FDA-2018-M-0620,
FDA-2018-M-0736, FDA-2018-M-0737, FDA-2018-M-00-0738, FDA-2018-M-0792,
FDA-2018-M-1371, FDA-2018-M-1215, FDA-2018-M-1237, FDA-2018-M-1372,
FDA-2018-M-1446, FDA-2018-M-1447, FDA-2018-M-1580, FDA-2018-M-1581,
FDA-2018-M-1634, FDA-2018-M-1727, FDA-2018-M-1791, FDA-2018-M-1753,
FDA-2018-M-1970, FDA-2018-M-2118, FDA-2018-M-2119, FDA-2018-M-2237,
FDA-2018-M-2269, FDA-2018-M-2335, FDA-2018-M-2460, FDA-2018-M-2461,
FDA-2018-M-2462, FDA-2018-M-2463, FDA-2018-M-2571, FDA-2018-M-2883,
FDA-2018-M-2884, FDA-2018-M-2885, FDA-2018-M-2886, FDA-2018-M-2887,
FDA-2018-M-2983, FDA-2018-M-3131, FDA-2018-M-3153, FDA-2018-M-3212,
FDA-2018-M-3503, FDA-2018-M-3505, and FDA-2018-M-3548 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.
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.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf .
[[Page 57731]]
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.
FOR FURTHER INFORMATION CONTACT: Joshua Nipper, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1650, Silver Spring, MD 20993-0002, 301-796-6524.
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 placed on the internet. 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 during that quarter. The following is a list of approved PMAs
for which summaries of safety and effectiveness were placed on the
internet from January 1, 2018, through September 18, 2018. 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
January 1, 2018, Through September 18, 2018
--------------------------------------------------------------------------------------------------------------------------------------------------------
PMA No., Docket No. Applicant Trade name Approval date
--------------------------------------------------------------------------------------------------------------------------------------------------------
P150005/S014, FDA-2017-M-6970................. Boston Scientific.................................... Blazer[supreg] Open-Irrigated 12/21/2017
Ablation Catheter and
IntellaNavTM Open-Irrigated
Ablation Catheter.
P100030/S008, FDA-2017-M-6971................. Mallinckrodt Pharma IP Trading DAC................... PREVELEAK Surgical Sealant....... 12/21/2017
P160012, FDA-2017-M-6983...................... Physio-Control, Inc.................................. LIFEPAK CR[supreg] Plus 12/21/2017
Defibrillator, LIFEPAK
EXPRESS[supreg] Defibrillator
and CHARGE-PAK[supreg] Battery
Charger.
P140032, FDA-2017-M-6984...................... Medtronic, Inc....................................... Implantable System for 12/22/2017
Remodulin[supreg].
P160022, FDA-2017-M-7004...................... ZOLL Medical Corp.................................... X Series[supreg], R 12/27/2017
Series[supreg], AED Pro[supreg],
and AED 3TM BLS[supreg]
Professional Defibrillators, Pro-
Padz Radiotransparent Electrode,
SurePowerTM Battery Pack,
SurePower IITM Battery Pack, AED
Pro[supreg] Non-Rechargeable
Lithium Battery Pack, AED 3TM
Battery Pack, SurePowerTM
Charger, and SurePowerTM Single
Bay Charger.
P170025, FDA-2018-M-0411...................... Hologic, Inc......................................... Aptima[supreg] HBV Quant Assay... 1/23/2018
P160032, FDA-2018-M-0528...................... Defibtech, LLC....................................... Lifeline/ReviveR DDU-100, 2/1/2018
Lifeline/ReviveR AUTO DDU-120,
Lifeline/ReviveR VIEW DDU-2300,
Lifeline/ReviveR VIEW AUTO DDU-
2200, Lifeline/ReviveR ECG DDU-
2450, and Lifeline/ReviveR ECG+
DDU-2475 Automated External
Defibrillators.
P140003/S018, FDA-2018-M-0620................. Abiomed, Inc......................................... Impella Ventricular Support 2/7/2018
Systems.
P160037, FDA-2018-M-0736...................... Becton, Dickinson and Co............................. BD Onclarity HPV Assay........... 2/12/2018
P150001/S021, FDA-2018-M-0737................. Medtronic MiniMed, Inc............................... MiniMed 630G System.............. 2/13/2018
P160017/S017, FDA-2018-M-0738................. Medtronic MiniMed, Inc............................... MiniMed 670G System.............. 2/13/2018
P960043/S097, FDA-2018-M-0792................. Abbott Vascular...................................... Perclose ProGlide[supreg] Suture- 2/16/2018
Mediated Closure System.
P160007, FDA-2018-M-1371...................... Medtronic MiniMed, Inc............................... Guardian Connect System.......... 3/8/2018
H170002, FDA-2018-M-1215...................... Kaneka Pharma America LLC............................ LIPOSORBER[supreg] LA-15 System.. 3/20/2018
P160013, FDA-2018-M-1237...................... TransMedics, Inc..................................... Organ Care System (OCSTM) Lung 3/22/2018
System.
P050006/S060, FDA-2018-M-1372................. W.L. Gore & Associates, Inc.......................... GORE[supreg] CARDIOFORM Septal 3/30/2018
Occluder.
P160018/S001, FDA-2018-M-1446................. Foundation Medicine, Inc............................. FoundationFocusTM CDx BRCA LOH... 4/6/2018
P150009, FDA-2018-M-1447...................... Angel Medical Systems, Inc........................... AngelMed Guardian System......... 4/9/2018
P160052, FDA-2018-M-1581...................... Parsagen Diagnostics, Inc............................ PartoSure Test................... 4/11/2018
P950039/S036, FDA-2018-M-1580................. Hologic, Inc......................................... ThinPrep Integrated Imager....... 4/18/2018
P140010/S037, FDA-2018-M-1634................. Medtronic Vascular, Inc.............................. IN.PACTTM AdmiralTM Paclitaxel- 4/19/2018
Coated Percutaneous Transluminal
Angioplasty (PTA) Balloon
Catheter.
P960009/S219, FDA-2018-M-1727................. Medtronic, Inc....................................... Medtronic DBS System for Epilepsy 4/27/2018
P170035, FDA-2018-M-1791...................... Bausch + Lomb, Inc................................... Bausch + Lomb ULTRA (samfilcon A) 4/30/2018
Contact Lenses.
P170016, FDA-2018-M-1753...................... Teva Pharmaceuticals USA, Inc........................ SYNOJOYNTTM...................... 5/8/2018
P040024/S099, FDA-2018-M-1970................. Galderma Laboratories, LP............................ Restylane[supreg] Lyft with 5/18/2018
Lidocaine.
P170013, FDA-2018-M-2118...................... MicroVention, Inc.................................... Low-Profile Visualized 5/30/2018
Intraluminal Support (LVIS) and
LVIS Jr.
P170039, FDA-2018-M-2119...................... Clinical Research Consultants, Inc................... CustomFlexTM Artificial Iris..... 5/30/2018
P910056/S027, FDA-2018-M-2237................. Bausch + Lomb, Inc................................... enVista[supreg] One-Piece 6/8/2018
Hydrophobic Acrylic Toric
Intraocular Lens (Model MX60T).
P150013/S009, FDA-2018-M-2269................. Dako North America, Inc.............................. PD-L1 IHC 22C3 pharmDx........... 6/12/2018
P100006/S005, FDA-2018-M-2335................. BioMimetic Therapeutics, LLC......................... AUGMENT[supreg] Injectable....... 6/12/2018
P170043, FDA-2018-M-2460...................... Glaukos Corp......................................... iStent inject Trabecular Micro- 6/21/2018
Bypass System (Model G2-M-IS).
[[Page 57732]]
P160017/S031, FDA-2018-M-2461................. Medtronic MiniMed, Inc............................... MiniMed 670G System.............. 6/21/2018
P160048, FDA-2018-M-2463...................... Senseonics, Inc...................................... Eversense Continuous Glucose 6/21/2018
Monitoring System.
P180008, FDA-2018-M-2462...................... Tandem Diabetes Care, Inc............................ t:slim X2 Insulin Pump with Basal- 6/21/2018
IQ Technology.
P180002, FDA-2018-M-2571...................... Pulmonx Corp......................................... Zephyr[supreg] Endobronchial 6/29/2018
Valve System.
P160026, FDA-2018-M-2883...................... Physio-Control, Inc.................................. LIFEPAK[supreg] 1000 7/2/2018
Defibrillator, LIFEPAK[supreg]
1000 Defibrillator Lithium-Ion
Rechargeable Battery,
LIFEPAK[supreg] 1000
Defibrillator Non-Rechargeable
Battery, LIFEPAK[supreg] 20
Defibrillator/Monitor
(Refurbished), LIFEPAK[supreg]
20e Defibrillator/Monitor,
LIFEPAK[supreg] 15 Monitor/
Defibrillator, LIFEPAK[supreg]
Lithium-ion Rechargeable Battery
(for use with the
LIFEPAK[supreg] 15 Monitor/
Defibrillator).
P170024, FDA-2018-M-2884...................... Stryker Neurovascular................................ Surpass Streamline Flow Diverter. 7/13/2018
P170041, FDA-2018-M-2885...................... Abbott Molecular, Inc................................ Abbott RealTime IDH1............. 7/20/2018
P160030/S017, FDA-2018-M-2886................. Abbott Diabetes Care Inc............................. FreeStyle Libre 14 Day Flash 7/23/2018
Glucose Monitoring System.
P160053, FDA-2018-M-2887...................... Endomagnetics Ltd.................................... MagtraceTM and Sentimag[supreg] 7/24/2018
Magnetic Localization System.
P170042, FDA-2018-M-2983...................... C.R. Bard, Inc....................................... COVERATM Vascular Covered Stent.. 7/30/2018
P150048/S012, FDA-2018-M-3131................. Edwards Lifesciences LLC............................. Edwards Pericardial Mitral 8/9/2018
Bioprosthesis, Model 11000M.
P170034, FDA-2018-M-3153...................... Ivantis, Inc......................................... Hydrus[supreg] Microstent........ 8/10/2018
P150013/S011, FDA-2018-M-3212................. Dako North America, Inc.............................. PD-L1 IHC 22C3 pharmDx........... 8/16/2018
P030016/S001, FDA-2018-M-3503................. STAAR Surgical Co.................................... Visian[supreg] TORIC ICL 9/13/2018
(Implantable Collamer[supreg]
Lens).
H170004, FDA-2018-M-3505...................... BIOTRONIK, Inc....................................... PK Papyrus Covered Coronary Stent 9/14/2018
System.
P180011, FDA-2018-M-3548...................... Boston Scientific Corp............................... ELUVIATM Drug-Eluting Vascular 9/18/2018
Stent System.
--------------------------------------------------------------------------------------------------------------------------------------------------------
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: November 13, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-25071 Filed 11-15-18; 8:45 am]
BILLING CODE 4164-01-P
