Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications, 23686-23688 [2018-10924]
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Federal Register / Vol. 83, No. 99 / Tuesday, May 22, 2018 / Notices
voting members. The Agency’s
regulations (21 CFR 14.22(d)) authorize
a committee charter to specify quorum
requirements.
If functioning as a medical device
panel, a non-voting representative of
consumer interests and a non-voting
representative of industry interests will
be included in addition to the voting
members.
Further information regarding the
most recent charter and other
information can be found at https://
www.fda.gov/AdvisoryCommittees/
CommitteesMeetingMaterials/Blood
VaccinesandOtherBiologics/
BloodProductsAdvisoryCommittee/
ucm121602.htm or by contacting the
Designated Federal Officer (see FOR
FURTHER INFORMATION CONTACT). In light
of the fact that no change has been made
to the committee name or description of
duties, no amendment will be made to
21 CFR 14.100.
This document is issued under the
Federal Advisory Committee Act (5
U.S.C. app.). For general information
related to FDA advisory committees,
please visit us at https://www.fda.gov/
AdvisoryCommittees/default.htm.
Dated: May 15, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–10848 Filed 5–21–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
amozie on DSK3GDR082PROD with NOTICES1
[Docket Nos. FDA–2017–M–3372, FDA–
2017–M–3951, FDA–2017–M–3990, FDA–
2017–M–4022, FDA–2017–M–4271, FDA–
2017–M–4498, FDA–2017–M–4756, FDA–
2017–M–4757, FDA–2017–M–4711, FDA–
2017–M–4904, FDA–2017–M–5320, FDA–
2017–M–5262, FDA–2017–M–5334, FDA–
2017–M–5438, FDA–2017–M–5813, FDA–
2017–M–5863, FDA–2017–M–5864, FDA–
2017–M–5884, FDA–2017–M–5929, FDA–
2017–M–5969, FDA–2017–M–5968, FDA–
2017–M–5997, FDA–2017–M–6223, FDA–
2017–M–6232, FDA–2017–M–6290, FDA–
2017–M–6524, FDA–2017–M–6525, FDA–
2017–M–6550, FDA–2017–M–6614, FDA–
2017–M–6650, FDA–2017–M–6799, FDA–
2017–M–6800, and FDA–2017–M–6896]
Medical Devices; Availability of Safety
and Effectiveness Summaries for
Premarket Approval Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is publishing a
list of premarket approval applications
SUMMARY:
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16:47 May 21, 2018
Jkt 241001
(PMAs) 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:
httpss://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–3372, FDA–2017–M–3951,
FDA–2017–M–3990, FDA–2017–M–
4022, FDA–2017–M–4271, FDA–2017–
M–4498, FDA–2017–M–4756, FDA–
2017–M–4757, FDA–2017–M–4711,
FDA–2017–M–4904, FDA–2017–M–
5320, FDA–2017–M–5262, FDA–2017–
M–5334, FDA–2017–M–5438, FDA–
2017–M–5813, FDA–2017–M–5863,
FDA–2017–M–5864, FDA–2017–M–
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
5884, FDA–2017–M–5929, FDA–2017–
M–5969, FDA–2017–M–5968, FDA–
2017–M–5997, FDA–2017–M–6223,
FDA–2017–M–6232, FDA–2017–M–
6290, FDA–2017–M–6524, FDA–2017–
M–6525, FDA–2017–M–6550, FDA–
2017–M–6614, FDA–2017–M–6650,
FDA–2017–M–6799, FDA–2017–M–
6800, and FDA–2017–M–6896 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.
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.
E:\FR\FM\22MYN1.SGM
22MYN1
Federal Register / Vol. 83, No. 99 / Tuesday, May 22, 2018 / Notices
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
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.
23687
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 July 1, 2017, through
December 31, 2017. 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 MADE AVAILABLE FROM JULY 1,
2017, THROUGH DECEMBER 31, 2017
PMA No., Docket No.
Applicant
Trade name
Plus®
Approval date
Plus®
P160015, FDA–2017–M–3372
P970003/S207, FDA–2017–M–
3951.
P150048, FDA–2017–M–3990
Zoll Medical Corporation .........
Cyberonics, Inc .......................
AED
and Fully Automatic AED
...........................
VNS Therapy System ..............................................................
5/26/2017
6/23/2017
Edwards Lifesciences, LLC ....
6/29/2017
P930016/S048, FDA–2017–M–
4022.
P130021/S033, FDA–2017–M–
4271.
AMO Manufacturing USA, LLC
P160049,
P170006,
P170005,
P160042,
Spectranetics Corp .................
Medtronic, Inc .........................
Abbott Molecular, Inc ..............
Prollenium Medical Technologies, Inc.
Boston Scientific
Neuromodulation Corporation.
Edwards Pericardial Aortic Bioprosthesis and Edwards
INSPIRIS RESILIA Aortic Valve.
STAR S4 IR Excimer Laser System and iDesign Advanced
WaveScan Studio System.
Medtronic CoreValveTM System, Medtronic CoreValveTM
EvolutTM R System and Medtronic CoreValveTM EvolutTM
PRO Systems.
Stellarex 0.035″ OTW Drug-coated Angioplasty Balloon ........
AvalusTM Bioprosthesis ............................................................
Abbott RealTime IDH2 .............................................................
Ravanesse Ultra .......................................................................
PrecisionTM Spinal Cord Stimulator System, Precision SpectraTM Spinal Cord Stimulator System, PrecisionTM NoviTM
Spinal Cord Stimulator System, PrecisionTM MontageTM
MRI Spinal Cord Stimulator System, PrecisionTM MontageTM Spinal Cord Stimulator System and Spectra
WaveWriterTM Spinal Cord Stimulator System.
HeartMate 3TM Left Ventricular Assist System ........................
t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM ............
8/11/2017
FDA–2017–M–4498
FDA–2017–M–4756
FDA–2017–M–4757
FDA–2017–M–4711
P030017/S275, FDA–2017–M–
4904.
Medtronic CoreValve LLC ......
Thoratec Corporation ..............
Tandem Diabetes Care, Inc ...
P170007, FDA–2017–M–5438
P150025/S003, FDA–2017–M–
5813.
P150042, FDA–2017–M–5863
P150045, FDA–2017–M–5864
P170011, FDA–2017–M–5884
P150013/S006, FDA–2017–M–
5929.
P160030, FDA–2017–M–5969
P100047/S090, FDA–2017–M–
5968.
P100021/S063, FDA–2017–M–
5997.
P160039, FDA–2017–M–6223
P170002, FDA–2017–M–6232
P150028/S001, FDA–2017–M–
6290.
amozie on DSK3GDR082PROD with NOTICES1
P160054, FDA–2017–M–5320
P140015/S020, FDA–2017–M–
5262.
P170003, FDA–2017–M–5334
H020002/S046, FDA–2017–
M–6524.
P160057, FDA–2017–M–6525
P160043/S001, FDA–2017–M–
6550.
P160055, FDA–2017–M–6614
P170008, FDA–2017–M–6650
P170019, FDA–2017–M–6799
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16:47 May 21, 2018
6/30/2017
7/10/2017
7/26/2017
7/31/2017
8/1/2017
8/4/2017
8/23/2017
8/25/2017
Bioventus LLC ........................
Dako North America, Inc ........
Lutonix® 035 Drug Coated Balloon PTA Catheter, Model
9010.
DUROLANE® ...........................................................................
PD–L1 IHC 28–8 pharmDx ......................................................
8/29/2017
9/15/2017
ZEUS Scientific, Inc ................
ZEUS Scientific, Inc ................
ABIOMED, Inc ........................
Dako North America, Inc ........
ZEUS ELISA Parvovirus B19 IgM Test System ......................
ZEUS ELISA Parvovirus B19 IgG Test System ......................
Impella RP® System ................................................................
PD–L1 IHC 22C3 pharmDx .....................................................
9/19/2017
9/19/2017
9/20/2017
9/22/2017
Abbott Diabetes Care, Inc ......
Medtronic, Inc .........................
Freestyle Libre Flash Glucose Monitoring System ..................
HeartWareTM HVADTM System ...............................................
9/27/2017
9/27/2017
Medtronic Vascular .................
Endurant II/Endurant IIs Stent Graft System ...........................
9/29/2017
Respicardia, Inc ......................
Teoxane S.A ...........................
NuMED, Inc ............................
10/6/2017
10/19/2017
10/24/2017
Stryker Neurovascular ............
¯
remede® System ......................................................................
RHA® 2, RHA® 3 and RHA® 4 ................................................
Cheatham Platinum (CP) Stent System (Covered CP Stent,
Model 427; Covered Mounted (CP) Stent, Model 428; CP
Stent, Model 425; Mounted CP Stent, Model 426).
Neuroform AtlasTM Stent System ............................................
OrthogenRx, Inc ......................
Medtronic Vascular .................
TriVisc ......................................................................................
Resolute OnyxTM Zotarolimus-Eluting Coronary Stent System
11/13/2017
11/16/2017
RxSight, Inc ............................
Medinol Ltd .............................
Foundation Medicine, Inc .......
Light Adjustable Lens (LAL) and Light Delivery Device (LDD)
EluNIR® Ridaforolimus Eluting Coronary Stent System ..........
FoundationOne CDx ................................................................
11/22/2017
11/28/2017
11/30/2017
Lutonix, Inc .............................
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8/25/2017
11/2/2017
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Federal Register / Vol. 83, No. 99 / Tuesday, May 22, 2018 / Notices
TABLE 1—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM JULY 1,
2017, THROUGH DECEMBER 31, 2017—Continued
PMA No., Docket No.
Applicant
Trade name
P150031, FDA–2017–M–6800
P170012, FDA–2017–M–6896
Boston Scientific Corporation
Biom’Up SA ............................
Vercise Deep Brain Stimulation (DBS) System .......................
HEMOBLASTTM Bellows .........................................................
II. Electronic Access
Persons with access to the internet
may obtain the documents at https://
www.fda.gov/MedicalDevices/
ProductsandMedicalProcedures/
DeviceApprovalsandClearances/
PMAApprovals/default.htm.
be submitted on or before July 23, 2018.
The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of July 23, 2018. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
Dated: May 17, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–10924 Filed 5–21–18; 8:45 am]
Electronic Submissions
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–1820]
Framework for Assessing pHDependent Drug-Drug Interactions;
Establishment of a Public Docket;
Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA) is establishing a
public docket to assist with the
development of a policy or guidance
document on the assessment of pHdependent drug-drug interactions
(DDIs). In October 2017, FDA published
two draft guidance documents on DDIs
entitled ‘‘In Vitro Metabolism- and
Transporter-Mediated Drug-Drug
Interaction Studies’’ (In Vitro Studies
Draft Guidance) and ‘‘Clinical Drug
Interaction Studies—Study Design, Data
Analysis, and Clinical Implications’’
(Clinical Drug Interaction Studies Draft
Guidance). These two draft guidances
focus on enzyme- and transporter-based
DDIs and do not include a framework to
assess pH-dependent DDIs. FDA is
seeking public input on best practices in
the planning and evaluation of pHdependent DDIs.
DATES: Submit either electronic or
written comments on this notice by July
23, 2018.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
amozie on DSK3GDR082PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
16:47 May 21, 2018
Jkt 241001
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.’’
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
Approval date
12/8/2017
12/15/2017
Instructions: All submissions received
must include the Docket No. FDA–
2018–N–1820 for ‘‘Framework for
Assessing pH-dependent Drug-Drug
Interactions; Establishment of Public
Docket; Request for Comments.’’
Received comments, those filed in a
timely manner (see ADDRESSES), 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.
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
E:\FR\FM\22MYN1.SGM
22MYN1
]]>Agencies
[Federal Register Volume 83, Number 99 (Tuesday, May 22, 2018)]
[Notices]
[Pages 23686-23688]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-10924]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2017-M-3372, FDA-2017-M-3951, FDA-2017-M-3990, FDA-
2017-M-4022, FDA-2017-M-4271, FDA-2017-M-4498, FDA-2017-M-4756, FDA-
2017-M-4757, FDA-2017-M-4711, FDA-2017-M-4904, FDA-2017-M-5320, FDA-
2017-M-5262, FDA-2017-M-5334, FDA-2017-M-5438, FDA-2017-M-5813, FDA-
2017-M-5863, FDA-2017-M-5864, FDA-2017-M-5884, FDA-2017-M-5929, FDA-
2017-M-5969, FDA-2017-M-5968, FDA-2017-M-5997, FDA-2017-M-6223, FDA-
2017-M-6232, FDA-2017-M-6290, FDA-2017-M-6524, FDA-2017-M-6525, FDA-
2017-M-6550, FDA-2017-M-6614, FDA-2017-M-6650, FDA-2017-M-6799, FDA-
2017-M-6800, and FDA-2017-M-6896]
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) 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: httpss://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-3372, FDA-2017-M-3951, FDA-2017-M-3990, FDA-2017-M-4022,
FDA-2017-M-4271, FDA-2017-M-4498, FDA-2017-M-4756, FDA-2017-M-4757,
FDA-2017-M-4711, FDA-2017-M-4904, FDA-2017-M-5320, FDA-2017-M-5262,
FDA-2017-M-5334, FDA-2017-M-5438, FDA-2017-M-5813, FDA-2017-M-5863,
FDA-2017-M-5864, FDA-2017-M-5884, FDA-2017-M-5929, FDA-2017-M-5969,
FDA-2017-M-5968, FDA-2017-M-5997, FDA-2017-M-6223, FDA-2017-M-6232,
FDA-2017-M-6290, FDA-2017-M-6524, FDA-2017-M-6525, FDA-2017-M-6550,
FDA-2017-M-6614, FDA-2017-M-6650, FDA-2017-M-6799, FDA-2017-M-6800, and
FDA-2017-M-6896 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.
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.
[[Page 23687]]
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 July 1, 2017, through December 31, 2017. 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 Made Available From July 1, 2017, Through
December 31, 2017
----------------------------------------------------------------------------------------------------------------
PMA No., Docket No. Applicant Trade name Approval date
----------------------------------------------------------------------------------------------------------------
P160015, FDA-2017-M-3372.............. Zoll Medical Corporation. AED Plus[supreg] and Fully 5/26/2017
Automatic AED Plus[supreg].
P970003/S207, FDA-2017-M-3951......... Cyberonics, Inc.......... VNS Therapy System........... 6/23/2017
P150048, FDA-2017-M-3990.............. Edwards Lifesciences, LLC Edwards Pericardial Aortic 6/29/2017
Bioprosthesis and Edwards
INSPIRIS RESILIA Aortic
Valve.
P930016/S048, FDA-2017-M-4022......... AMO Manufacturing USA, STAR S4 IR Excimer Laser 6/30/2017
LLC. System and iDesign Advanced
WaveScan Studio System.
P130021/S033, FDA-2017-M-4271......... Medtronic CoreValve LLC.. Medtronic CoreValveTM System, 7/10/2017
Medtronic CoreValveTM
EvolutTM R System and
Medtronic CoreValveTM
EvolutTM PRO Systems.
P160049, FDA-2017-M-4498.............. Spectranetics Corp....... Stellarex 0.035'' OTW Drug- 7/26/2017
coated Angioplasty Balloon.
P170006, FDA-2017-M-4756.............. Medtronic, Inc........... AvalusTM Bioprosthesis....... 7/31/2017
P170005, FDA-2017-M-4757.............. Abbott Molecular, Inc.... Abbott RealTime IDH2......... 8/1/2017
P160042, FDA-2017-M-4711.............. Prollenium Medical Ravanesse Ultra.............. 8/4/2017
Technologies, Inc.
P030017/S275, FDA-2017-M-4904......... Boston Scientific PrecisionTM Spinal Cord 8/11/2017
Neuromodulation Stimulator System, Precision
Corporation. SpectraTM Spinal Cord
Stimulator System,
PrecisionTM NoviTM Spinal
Cord Stimulator System,
PrecisionTM MontageTM MRI
Spinal Cord Stimulator
System, PrecisionTM
MontageTM Spinal Cord
Stimulator System and
Spectra WaveWriterTM Spinal
Cord Stimulator System.
P160054, FDA-2017-M-5320.............. Thoratec Corporation..... HeartMate 3TM Left 8/23/2017
Ventricular Assist System.
P140015/S020, FDA-2017-M-5262......... Tandem Diabetes Care, Inc t:slim X2 Insulin Pump with 8/25/2017
Dexcom G5 Mobile CGM.
P170003, FDA-2017-M-5334.............. Lutonix, Inc............. Lutonix[supreg] 035 Drug 8/25/2017
Coated Balloon PTA Catheter,
Model 9010.
P170007, FDA-2017-M-5438.............. Bioventus LLC............ DUROLANE[supreg]............. 8/29/2017
P150025/S003, FDA-2017-M-5813......... Dako North America, Inc.. PD-L1 IHC 28-8 pharmDx....... 9/15/2017
P150042, FDA-2017-M-5863.............. ZEUS Scientific, Inc..... ZEUS ELISA Parvovirus B19 IgM 9/19/2017
Test System.
P150045, FDA-2017-M-5864.............. ZEUS Scientific, Inc..... ZEUS ELISA Parvovirus B19 IgG 9/19/2017
Test System.
P170011, FDA-2017-M-5884.............. ABIOMED, Inc............. Impella RP[supreg] System.... 9/20/2017
P150013/S006, FDA-2017-M-5929......... Dako North America, Inc.. PD-L1 IHC 22C3 pharmDx....... 9/22/2017
P160030, FDA-2017-M-5969.............. Abbott Diabetes Care, Inc Freestyle Libre Flash Glucose 9/27/2017
Monitoring System.
P100047/S090, FDA-2017-M-5968......... Medtronic, Inc........... HeartWareTM HVADTM System.... 9/27/2017
P100021/S063, FDA-2017-M-5997......... Medtronic Vascular....... Endurant II/Endurant IIs 9/29/2017
Stent Graft System.
P160039, FDA-2017-M-6223.............. Respicardia, Inc......... remed[emacr][supreg] System.. 10/6/2017
P170002, FDA-2017-M-6232.............. Teoxane S.A.............. RHA[supreg] 2, RHA[supreg] 3 10/19/2017
and RHA[supreg] 4.
P150028/S001, FDA-2017-M-6290......... NuMED, Inc............... Cheatham Platinum (CP) Stent 10/24/2017
System (Covered CP Stent,
Model 427; Covered Mounted
(CP) Stent, Model 428; CP
Stent, Model 425; Mounted CP
Stent, Model 426).
H020002/S046, FDA-2017-M-6524......... Stryker Neurovascular.... Neuroform AtlasTM Stent 11/2/2017
System.
P160057, FDA-2017-M-6525.............. OrthogenRx, Inc.......... TriVisc...................... 11/13/2017
P160043/S001, FDA-2017-M-6550......... Medtronic Vascular....... Resolute OnyxTM Zotarolimus- 11/16/2017
Eluting Coronary Stent
System.
P160055, FDA-2017-M-6614.............. RxSight, Inc............. Light Adjustable Lens (LAL) 11/22/2017
and Light Delivery Device
(LDD).
P170008, FDA-2017-M-6650.............. Medinol Ltd.............. EluNIR[supreg] Ridaforolimus 11/28/2017
Eluting Coronary Stent
System.
P170019, FDA-2017-M-6799.............. Foundation Medicine, Inc. FoundationOne CDx............ 11/30/2017
[[Page 23688]]
P150031, FDA-2017-M-6800.............. Boston Scientific Vercise Deep Brain 12/8/2017
Corporation. Stimulation (DBS) System.
P170012, FDA-2017-M-6896.............. Biom'Up SA............... HEMOBLASTTM Bellows.......... 12/15/2017
----------------------------------------------------------------------------------------------------------------
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: May 17, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-10924 Filed 5-21-18; 8:45 am]
BILLING CODE 4164-01-P
