Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications, 44626-44628 [2017-20391]
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44626
Federal Register / Vol. 82, No. 184 / Monday, September 25, 2017 / Notices
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Dated: September 19, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–20375 Filed 9–22–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2015–M–4474, FDA–
2016–M–1915, FDA–2016–M–1837, FDA–
2016–M–1916, FDA–2016–M–1914, FDA–
2016–M–1917, FDA–2016–M–2182, FDA–
2016–M–2183, FDA–2016–M–2184, FDA–
2016–M–2185, FDA–2016–M–2332, FDA–
2016–M–2334, FDA–2016–M–2333, FDA–
2016–M–2485, FDA–2016–M–2498, FDA–
2016–M–2499, FDA–2016–M–2500, FDA–
2016–M–2649, FDA–2016–M–2650, FDA–
2016–M–2651, FDA–2016–M–2735, FDA–
2016–M–2974, FDA–2016–M–2971, FDA–
2016–M–1972, FDA–2016–M–2973, FDA–
2016–M–2975, FDA–2016–M–3430, FDA–
2016–M–3431, FDA–2016–M–3913, FDA–
2016–M–3653, FDA–2016–M–3914, FDA–
2016–M–3915, FDA–2016–M–4046, FDA–
2016–M–4344, FDA–2016–M–4458, FDA–
2016–M–4459, FDA–2016–M–4483, FDA–
2016–M–4657, FDA–2016–M–4530, FDA–
2016–M–4653, FDA–2017–M–0180, FDA–
2017–M–0181, FDA–2017–M–0229, FDA–
2017–M–0560, FDA–2017–M–0831, FDA–
2017–M–0661, FDA–2017–M–0971, FDA–
2017–M–2652, FDA–2017–M–1121, FDA–
2017–M–1122, FDA–2017–M–1228, FDA–
2017–M–1845, FDA–2017–M–1227, FDA–
2017–M–1713, FDA–2017–M–1714, FDA–
2017–M–1950, FDA–2017–M–2594, FDA–
2017–M–2766, FDA–2017–M–2767, FDA–
2017–M–2768, FDA–2017–M–3103, FDA–
2017–M–3200, FDA–2017–M–3430, FDA–
2017–M–3579, FDA–2017–M–3580, FDA–
2017–M–3778, FDA–2017–M–3839, FDA–
2017–M–3928, FDA–2017–M–3982, FDA–
2017–M–3990, and FDA–2017–M–3983]
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
(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:
asabaliauskas on DSKBBXCHB2PROD with NOTICES
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
VerDate Sep<11>2014
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Jkt 241001
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–
2015–M–4474, FDA–2016–M–1915,
FDA–2016–M–1837, FDA–2016–M–
1916, FDA–2016–M–1914, FDA–2016–
M–1917, FDA–2016–M–2182, FDA–
2016–M–2183, FDA–2016–M–2184,
FDA–2016–M–2185, FDA–2016–M–
2332, FDA–2016–M–2334, FDA–2016–
M–2333, FDA–2016–M–2485, FDA–
2016–M–2498, FDA–2016–M–2499,
FDA–2016–M–2500, FDA–2016–M–
2649, FDA–2016–M–2650, FDA–2016–
M–2651, FDA–2016–M–2735, FDA–
2016–M–2974, FDA–2016–M–2971,
FDA–2016–M–1972, FDA–2016–M–
2973, FDA–2016–M–2975, FDA–2016–
M–3430, FDA–2016–M–3431, FDA–
2016–M–3913, FDA–2016–M–3653,
FDA–2016–M–3914, FDA–2016–M–
3915, FDA–2016–M–4046, FDA–2016–
M–4344, FDA–2016–M–4458, FDA–
2016–M–4459, FDA–2016–M–4483,
FDA–2016–M–4657, FDA–2016–M–
4530, FDA–2016–M–4653, FDA–2017–
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2017–M–0229, FDA–2017–M–0560,
FDA–2017–M–0831, FDA–2017–M–
0661, FDA–2017–M–0971, FDA–2017–
M–2652, FDA–2017–M–1121, FDA–
2017–M–1122, FDA–2017–M–1228,
FDA–2017–M–1845, FDA–2017–M–
1227, FDA–2017–M–1713, FDA–2017–
M–1714, FDA–2017–M–1950, FDA–
2017–M–2594, FDA–2017–M–2766,
FDA–2017–M–2767, FDA–2017–M–
2768, FDA–2017–M–3103, FDA–2017–
M–3200, FDA–2017–M–3430, FDA–
2017–M–3579, FDA–2017–M–3580,
FDA–2017–M–3778, FDA–2017–M–
3839, FDA–2017–M–3928, FDA–2017–
M–3982, FDA–2017–M–3990, and FDA–
2017–M–3983 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
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Dockets Management Staff between 9
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Federal Register / Vol. 82, No. 184 / Monday, September 25, 2017 / Notices
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 (the 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
44627
period will begin when the applicant is
notified by FDA in writing of its
decision.
The regulations provide that FDA
publish a quarterly 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, 2016, through June
30, 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,
2016 THROUGH JUNE 30, 2017
Approval
date
Applicant
Trade name
P130018, FDA–2015–M–4474 ..........
P140003/S004, FDA–2016–M–1915
P150034, FDA–2016–M–1837 ..........
P150017, FDA–2016–M–1916 ..........
P150023, FDA–2016–M–1914 ..........
P100020/S017, FDA–2016–M–1917
P090029/S003, FDA–2016–M–2182
P150038, FDA–2016–M–2183 ..........
P980040/S065, FDA–2016–M–2184
P150006, FDA–2016–M–2185 ..........
P160004, FDA–2016–M–2332 ..........
P150003/S003, FDA–2016–M–2334
Uromedica, Inc .................................
Abiomed, Inc ....................................
Revision Optics, Inc .........................
Cartiva, Inc .......................................
Abbott Vascular ................................
Roche Molecular Systems, Inc ........
Medtronic Sofamor Danek USA, Inc
InSightec, Inc ...................................
Abbott Medical Optics, Inc ...............
Vasorum, Ltd ....................................
W.L. Gore & Associates, Inc ...........
Boston Scientific Corp .....................
P150037, FDA–2016–M–2333 ..........
P150001, FDA–2016–M–2500 ..........
P150036, FDA–2016–M–2485 ..........
P130009/S057, FDA–2016–M–2498
P140031/S010, FDA–2016–M–2499
P020045/S073, 2016–M–2649 ..........
P140010/S015, FDA–2016–M–2650
Alcon Laboratories, Inc ....................
Medtronic MiniMed ...........................
Edwards Lifesciences, LLC .............
Edwards Lifesciences LLC ..............
Edwards Lifesciences LLC ..............
Medtronic, Inc ..................................
Medtronic Vascular, Inc ...................
P160001, FDA–2016–M–2651 ..........
P150040, FDA–2016–M–2735 ..........
P000025/S084, FDA–2016–M–2974
P150021, FDA–2016–M–2971 ..........
P080020/S020, FDA–2016–M–2975
P160017, FDA–2016–M–1972 ..........
P150044, FDA–2016–M–2973 ..........
P150030, FDA–2016–M–3430 ..........
P160006, FDA–2016–M–3431 ..........
P150013/S001, FDA–2016–M–3913
P120021, FDA–2016–M–3653 ..........
P150043, FDA–2016–M–3914 ..........
P930016/S045, FDA–2016–M–3915
Obalon Therapeutics, Inc .................
Carl Zeiss Meditec, Inc ....................
MED–EL Corp ..................................
Abbott Diabetes Care, Inc ...............
Seikagaku Corp ...............................
Medtronic MiniMed, Inc ....................
Roche Molecular Systems, Inc ........
Smith & Nephew, Inc .......................
Ventana Medical Systems, Inc ........
Dako North America, Inc .................
St. Jude Medical, Inc .......................
QView Medical, Inc ..........................
AMO Manufacturing USA, LLC ........
P020050/S023, FDA–2016–M–4046
Alcon Laboratories, Inc ....................
P140029, FDA–2016–M–4344 ..........
P130007/S016, FDA–2016–M–4458
P160018, FDA–2016–M–4459 ..........
P120005/S041, FDA–2016–M–4483
P040020/S049, FDA–2016–M–4657
P160019, FDA–2016–M–4530 ..........
asabaliauskas on DSKBBXCHB2PROD with NOTICES
PMA No., Docket No.
Q-Med AB ........................................
Animas Corporation .........................
Foundation Medicine, Inc .................
Dexcom, Inc .....................................
Alcon Laboratories, Inc ....................
Roche Diagnostics ...........................
P100022/S020, FDA–2016–M–4653
H070005, FDA–2017–M–0180 ..........
P160031, FDA–2017–M–0181 ..........
P160008, FDA–2017–M–0229 ..........
Cook Medical Inc .............................
AGA Medical Corp ...........................
FUJIFILM Medical Systems U.S.A.,
Inc.
HeartSine Technologies LLC ...........
ProACTTM Adjustable Continence Therapy for Men ..................................
Impella Ventricular Support ........................................................................
Raindrop Near Vision Inlay ........................................................................
Cartiva Synthetic Cartilage Implant ............................................................
Absorb GT1TM Bioresorbable Vascular Scaffold (BVS) System ...............
cobas® HPV Test .......................................................................................
Prestige LPTM Cervical Disc .......................................................................
ExAblate Model 4000 Type 1.0 System (ExAblate Neuro) ........................
TECNIS® Symfony Extended Range of Vision Intraocular Lens ...............
Celt ACD Vascular Closure Device ............................................................
Gore TIGRIS Vascular Stent ......................................................................
SYNERGYTM Everolimus-Eluting Platinum Chromium Coronary Stent
System (Over-The-Wire & Monorail).
CyPass® System (Model 241–S) ...............................................................
MiniMed 630G System with SmartGuard ...................................................
Edwards INTUITY Elite Valve System .......................................................
Edwards SAPIEN XT Transcatheter Heart Valve ......................................
Edwards SAPIEN 3 Transcatheter Heart Valve .........................................
Freezor® Xtra Cardiac Cryoablation Catheter ...........................................
In PactTM AdmiralTM Paclitaxel-Coated Percutaneous Transluminal
Angioplasty Balloon Catheter.
Obalon Balloon System ..............................................................................
VisuMax® Femtosecond Laser ...................................................................
MED–EL Cochlear Implant System ............................................................
Freestyle Libre Pro Flash Glucose Monitoring System .............................
Gel-One® ....................................................................................................
MiniMed 670G System ...............................................................................
cobas® EGFR Mutation Test v2 .................................................................
R3TM delta Ceramic Acetabular System ....................................................
VENTANA PD–L1 (SP142) Assay .............................................................
PD–L1 IHC 22C3 pharmDX .......................................................................
AmplatzerTM PFO Occluder .......................................................................
QVCAD System ..........................................................................................
Star S4 IR Excimer Laser System and iDesign Advanced WaveScan
Studio.
WaveLight® EX500 and ALLEGRETTO WAVE® EYE–Q Excimer Laser
Systems.
Restylane® Refyne and Restylane® Defyne ..............................................
OneTouch VibeTM Plus System .................................................................
FoundationFocusTM CDxBRACA Assay .......................................................
Dexcom G5 Mobile Continuous Glucose Monitoring System ....................
Acrysof® IQ ReSTOR® +3.0 D Multifocal Toric Intraocular Lens ..............
Elecsys HBsAg II/Elecsys HBsAg Confirmatory Test/PreciControl HBsAg
II.
Zilver PTX Drug-Eluting Peripheral Stent ..................................................
AMPLATZERTM Post-Infarct Muscular VSD Occluder ...............................
ASPIRE Cristalle Digital Breast Tomosynthesis Option ............................
P160021, FDA–2017–M–0560 ..........
P130024/S009, FDA–2017–M–0831
P140033, FDA–2017–M–0661 ..........
W.L. Gore & Associates, Inc ...........
Lutonix, Inc .......................................
St. Jude Medical, Inc .......................
P160023, FDA–2017–M–0971 ..........
Hologic, Inc ......................................
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HeartSine samaritan® SAM 350P, SAM 360P, and SAM 450P Public
Access Automated External Defibrillators, Accessories and Saver
EVO® Software Version 1.4.0.
Gore® Viabahn® VBX Balloon Expandable Endoprosthesis .....................
Lutonix® 035 Drug Coated Balloon PTA Catheter .....................................
MR Conditional Pacemaker System—Assurity MRITM and Endurity
MRITM Pacemakers and Tendril MRITM 1200M LPA Lead.
Aptima® HCV Quant Dx Assay ..................................................................
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Federal Register / Vol. 82, No. 184 / Monday, September 25, 2017 / Notices
TABLE 1—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM JULY 1,
2016 THROUGH JUNE 30, 2017—Continued
Approval
date
PMA No., Docket No.
Applicant
Trade name
P160003, FDA–2016–M–2652 ..........
P150039, FDA–2017–M–1121 ..........
P160014, FDA–2017–M–1122 ..........
P100044/S023, FDA–2017–M–1228
P140017/S005, FDA–2017–M–1227
Biotronik, Inc ....................................
Tryton Medical, Inc ..........................
CeloNova BioSciences, Inc .............
Intersect ENT ...................................
Medtronic, Inc ..................................
2/14/2017
2/21/2017
2/21/2017
2/23/2017
2/24/2017
P160016, FDA–2017–M–1713 ..........
P110033/S020, FDA–2017–M–1714
P160025, FDA–2017–M–1845 ..........
P160009, FDA–2017–M–1950 ..........
P160024, FDA–2017–M–2594 ..........
P160043, FDA–2017–M–2767 ..........
P160040, FDA–2017–M–2766 ..........
P160046, FDA–2017–M–2768 ..........
H150003, FDA–2017–M–3103 ..........
P160044, FDA–2017–M–3200 ..........
P160041, FDA–2017–M–3430 ..........
P140031/S028, FDA–2017–M–3579
P160035, FDA–2017–M–3580 ..........
P160047, FDA–2017–M–3778 ..........
H160002, FDA–2017–M–3839 ..........
P160045, FDA–2017–M–3928 ..........
P150046, FDA–2017–M–3982 ..........
P150048, FDA–2017–M–3990 ..........
Siemens Healthcare Diagnostics,
Inc.
Allergan ............................................
Biotronik, Inc ....................................
iCAD, Inc ..........................................
Bard Peripheral Vascular, Inc ..........
Medtronic, Inc ..................................
Invivoscribe Technologies, Inc .........
Ventana Medical Systems, Inc ........
Wilson-Cook Medical, Inc ................
Abbott Molecular, Inc .......................
Roche Molecular Systems, Inc ........
Edwards Lifesciences LLC ..............
Berlin Heart, Inc ...............................
AEGEA Medical, Inc ........................
Pulsar Vascular, Inc .........................
Life Technologies Corp ....................
SciBase AB ......................................
Edwards Lifesciences, LLC .............
PRO-Kinetic Energy Cobalt Chromium Coronary Stent System ...............
TRYTON Side Branch Stent ......................................................................
COBRA PzFTM NanoCoated Coronary Stent System ...............................
PROPEL® Contour Sinus Implant ..............................................................
MelodyTM Transcatheter Pulmonary Valve, EnsembleTM Transcatheter
Valve Delivery System and EnsembleTM II Transcatheter Valve Delivery System.
VERSANT® HCV GENOTYPE 2.0 Assay (LiPA) ......................................
3/17/2017
3/23/2017
3/24/2017
4/24/2017
4/28/2017
4/28/2017
5/1/2017
5/12/2017
5/18/2017
6/1/2017
6/5/2017
6/6/2017
6/14/2017
6/19/2017
6/22/2017
6/28/2017
6/29/2017
P160038, FDA–2017–M–3983 ..........
Illumina, Inc ......................................
´
Juvederm VollureTM XC .............................................................................
Astron Pulsar and Pulsar-18 Stent Systems ..............................................
PowerLook® Tomo Detection Software .....................................................
LifeStream Balloon Expandable Vascular Covered Stent .........................
Resolute Onyx Zotarolimus- Eluting Coronary Stent System ....................
LeukoStrat® CDx FLT3 Mutation Assay ....................................................
VENTANA PD–L1 (SP263) Assay .............................................................
FlourishTM Pediatric Esophageal Atresia Device .......................................
Abbott RealTime CMV ................................................................................
cobas® CMV ...............................................................................................
Edwards SAPIEN 3TM Transcatheter Heart Valve and Accessories .........
EXCOR® Pediatric Ventricular Assist Device ............................................
AEGEA Vapor SystemTM ...........................................................................
PulseRider® Aneurysm Neck Reconstruction Device (‘‘PulseRider’’) .......
OncomineTM Dx Target Test ......................................................................
Nevisense ...................................................................................................
Edwards Pericardial Aortic Bioprosthesis and Edwards INSPIRIS
RESILIA Aortic Valve.
PraxisTM Extended RAS Panel ..................................................................
sell, distributes, or imports cigars in
small packages with respect to the
warning statement requirements in
FDA’s regulations deeming other
products that meet the statutory
definition of a tobacco product to be
subject to Chapter IX of the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act). The guidance describes
FDA’s compliance policy for cigars in
packaging that is too small or otherwise
unable to accommodate a label with
sufficient space to bear the required
warning statements. The guidance
explains that FDA does not intend to
take enforcement action with respect to
cigars that do not comply with the size
and placement requirements in the
regulation when the information and
specifications required under the
regulation appear on the carton or other
outer container or wrapper that could
accommodate the required warning
statements, or on a tag otherwise firmly
and permanently affixed to the cigar
package.
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: September 12, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–20391 Filed 9–22–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–D–0121]
Compliance Policy for Required
Warning Statements on SmallPackaged Cigars; Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
asabaliauskas on DSKBBXCHB2PROD with NOTICES
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘Compliance Policy for
Required Warning Statements on SmallPackaged Cigars.’’ The guidance is
intended to assist any person who
manufactures, packages, sells, offers to
SUMMARY:
VerDate Sep<11>2014
19:45 Sep 22, 2017
Jkt 241001
The announcement of the
guidance is published in the Federal
Register on September 25, 2017.
DATES:
You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
ADDRESSES:
Electronic Submissions
Submit electronic comments in the
following way:
PO 00000
Frm 00074
Fmt 4703
Sfmt 4703
3/14/2017
6/29/2017
• 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
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Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
E:\FR\FM\25SEN1.SGM
25SEN1
]]>Agencies
[Federal Register Volume 82, Number 184 (Monday, September 25, 2017)]
[Notices]
[Pages 44626-44628]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-20391]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2015-M-4474, FDA-2016-M-1915, FDA-2016-M-1837, FDA-
2016-M-1916, FDA-2016-M-1914, FDA-2016-M-1917, FDA-2016-M-2182, FDA-
2016-M-2183, FDA-2016-M-2184, FDA-2016-M-2185, FDA-2016-M-2332, FDA-
2016-M-2334, FDA-2016-M-2333, FDA-2016-M-2485, FDA-2016-M-2498, FDA-
2016-M-2499, FDA-2016-M-2500, FDA-2016-M-2649, FDA-2016-M-2650, FDA-
2016-M-2651, FDA-2016-M-2735, FDA-2016-M-2974, FDA-2016-M-2971, FDA-
2016-M-1972, FDA-2016-M-2973, FDA-2016-M-2975, FDA-2016-M-3430, FDA-
2016-M-3431, FDA-2016-M-3913, FDA-2016-M-3653, FDA-2016-M-3914, FDA-
2016-M-3915, FDA-2016-M-4046, FDA-2016-M-4344, FDA-2016-M-4458, FDA-
2016-M-4459, FDA-2016-M-4483, FDA-2016-M-4657, FDA-2016-M-4530, FDA-
2016-M-4653, FDA-2017-M-0180, FDA-2017-M-0181, FDA-2017-M-0229, FDA-
2017-M-0560, FDA-2017-M-0831, FDA-2017-M-0661, FDA-2017-M-0971, FDA-
2017-M-2652, FDA-2017-M-1121, FDA-2017-M-1122, FDA-2017-M-1228, FDA-
2017-M-1845, FDA-2017-M-1227, FDA-2017-M-1713, FDA-2017-M-1714, FDA-
2017-M-1950, FDA-2017-M-2594, FDA-2017-M-2766, FDA-2017-M-2767, FDA-
2017-M-2768, FDA-2017-M-3103, FDA-2017-M-3200, FDA-2017-M-3430, FDA-
2017-M-3579, FDA-2017-M-3580, FDA-2017-M-3778, FDA-2017-M-3839, FDA-
2017-M-3928, FDA-2017-M-3982, FDA-2017-M-3990, and FDA-2017-M-3983]
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: 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-2015-M-4474, FDA-2016-M-1915, FDA-2016-M-1837, FDA-2016-M-1916,
FDA-2016-M-1914, FDA-2016-M-1917, FDA-2016-M-2182, FDA-2016-M-2183,
FDA-2016-M-2184, FDA-2016-M-2185, FDA-2016-M-2332, FDA-2016-M-2334,
FDA-2016-M-2333, FDA-2016-M-2485, FDA-2016-M-2498, FDA-2016-M-2499,
FDA-2016-M-2500, FDA-2016-M-2649, FDA-2016-M-2650, FDA-2016-M-2651,
FDA-2016-M-2735, FDA-2016-M-2974, FDA-2016-M-2971, FDA-2016-M-1972,
FDA-2016-M-2973, FDA-2016-M-2975, FDA-2016-M-3430, FDA-2016-M-3431,
FDA-2016-M-3913, FDA-2016-M-3653, FDA-2016-M-3914, FDA-2016-M-3915,
FDA-2016-M-4046, FDA-2016-M-4344, FDA-2016-M-4458, FDA-2016-M-4459,
FDA-2016-M-4483, FDA-2016-M-4657, FDA-2016-M-4530, FDA-2016-M-4653,
FDA-2017-M-0180, FDA-2017-M-0181, FDA-2017-M-0229, FDA-2017-M-0560,
FDA-2017-M-0831, FDA-2017-M-0661, FDA-2017-M-0971, FDA-2017-M-2652,
FDA-2017-M-1121, FDA-2017-M-1122, FDA-2017-M-1228, FDA-2017-M-1845,
FDA-2017-M-1227, FDA-2017-M-1713, FDA-2017-M-1714, FDA-2017-M-1950,
FDA-2017-M-2594, FDA-2017-M-2766, FDA-2017-M-2767, FDA-2017-M-2768,
FDA-2017-M-3103, FDA-2017-M-3200, FDA-2017-M-3430, FDA-2017-M-3579,
FDA-2017-M-3580, FDA-2017-M-3778, FDA-2017-M-3839, FDA-2017-M-3928,
FDA-2017-M-3982, FDA-2017-M-3990, and FDA-2017-M-3983 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
[[Page 44627]]
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 (the 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 quarterly 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, 2016, through June 30, 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, 2016 Through
June 30, 2017
----------------------------------------------------------------------------------------------------------------
Approval
PMA No., Docket No. Applicant Trade name date
----------------------------------------------------------------------------------------------------------------
P130018, FDA-2015-M-4474............... Uromedica, Inc............ ProACTTM Adjustable Continence 11/24/15
Therapy for Men.
P140003/S004, FDA-2016-M-1915.......... Abiomed, Inc.............. Impella Ventricular Support... 4/7/2016
P150034, FDA-2016-M-1837............... Revision Optics, Inc...... Raindrop Near Vision Inlay.... 6/29/2016
P150017, FDA-2016-M-1916............... Cartiva, Inc.............. Cartiva Synthetic Cartilage 7/1/2016
Implant.
P150023, FDA-2016-M-1914............... Abbott Vascular........... Absorb GT1TM Bioresorbable 7/5/2016
Vascular Scaffold (BVS)
System.
P100020/S017, FDA-2016-M-1917.......... Roche Molecular Systems, cobas[supreg] HPV Test........ 7/7/2016
Inc.
P090029/S003, FDA-2016-M-2182.......... Medtronic Sofamor Danek Prestige LPTM Cervical Disc... 7/7/2016
USA, Inc.
P150038, FDA-2016-M-2183............... InSightec, Inc............ ExAblate Model 4000 Type 1.0 7/11/2016
System (ExAblate Neuro).
P980040/S065, FDA-2016-M-2184.......... Abbott Medical Optics, Inc TECNIS[supreg] Symfony 7/15/2016
Extended Range of Vision
Intraocular Lens.
P150006, FDA-2016-M-2185............... Vasorum, Ltd.............. Celt ACD Vascular Closure 7/20/2016
Device.
P160004, FDA-2016-M-2332............... W.L. Gore & Associates, Gore TIGRIS Vascular Stent.... 7/27/2016
Inc.
P150003/S003, FDA-2016-M-2334.......... Boston Scientific Corp.... SYNERGYTM Everolimus-Eluting 7/29/2016
Platinum Chromium Coronary
Stent System (Over-The-Wire &
Monorail).
P150037, FDA-2016-M-2333............... Alcon Laboratories, Inc... CyPass[supreg] System (Model 7/29/2016
241-S).
P150001, FDA-2016-M-2500............... Medtronic MiniMed......... MiniMed 630G System with 8/10/2016
SmartGuard.
P150036, FDA-2016-M-2485............... Edwards Lifesciences, LLC. Edwards INTUITY Elite Valve 8/12/2016
System.
P130009/S057, FDA-2016-M-2498.......... Edwards Lifesciences LLC.. Edwards SAPIEN XT 8/18/2016
Transcatheter Heart Valve.
P140031/S010, FDA-2016-M-2499.......... Edwards Lifesciences LLC.. Edwards SAPIEN 3 Transcatheter 8/18/2016
Heart Valve.
P020045/S073, 2016-M-2649.............. Medtronic, Inc............ Freezor[supreg] Xtra Cardiac 8/31/2016
Cryoablation Catheter.
P140010/S015, FDA-2016-M-2650.......... Medtronic Vascular, Inc... In PactTM AdmiralTM Paclitaxel- 9/7/2016
Coated Percutaneous
Transluminal Angioplasty
Balloon Catheter.
P160001, FDA-2016-M-2651............... Obalon Therapeutics, Inc.. Obalon Balloon System......... 9/8/2016
P150040, FDA-2016-M-2735............... Carl Zeiss Meditec, Inc... VisuMax[supreg] Femtosecond 9/13/2016
Laser.
P000025/S084, FDA-2016-M-2974.......... MED-EL Corp............... MED-EL Cochlear Implant System 9/15/2016
P150021, FDA-2016-M-2971............... Abbott Diabetes Care, Inc. Freestyle Libre Pro Flash 9/23/2016
Glucose Monitoring System.
P080020/S020, FDA-2016-M-2975.......... Seikagaku Corp............ Gel-One[supreg]............... 9/27/2016
P160017, FDA-2016-M-1972............... Medtronic MiniMed, Inc.... MiniMed 670G System........... 9/28/2016
P150044, FDA-2016-M-2973............... Roche Molecular Systems, cobas[supreg] EGFR Mutation 9/28/2016
Inc. Test v2.
P150030, FDA-2016-M-3430............... Smith & Nephew, Inc....... R3TM delta Ceramic Acetabular 10/17/2016
System.
P160006, FDA-2016-M-3431............... Ventana Medical Systems, VENTANA PD-L1 (SP142) Assay... 10/18/2016
Inc.
P150013/S001, FDA-2016-M-3913.......... Dako North America, Inc... PD-L1 IHC 22C3 pharmDX........ 10/24/2016
P120021, FDA-2016-M-3653............... St. Jude Medical, Inc..... AmplatzerTM PFO Occluder...... 10/28/2016
P150043, FDA-2016-M-3914............... QView Medical, Inc........ QVCAD System.................. 11/9/2016
P930016/S045, FDA-2016-M-3915.......... AMO Manufacturing USA, LLC Star S4 IR Excimer Laser 11/14/2016
System and iDesign Advanced
WaveScan Studio.
P020050/S023, FDA-2016-M-4046.......... Alcon Laboratories, Inc... WaveLight[supreg] EX500 and 11/21/2016
ALLEGRETTO WAVE[supreg] EYE-Q
Excimer Laser Systems.
P140029, FDA-2016-M-4344............... Q-Med AB.................. Restylane[supreg] Refyne and 12/9/2016
Restylane[supreg] Defyne.
P130007/S016, FDA-2016-M-4458.......... Animas Corporation........ OneTouch VibeTM Plus System... 12/16/2016
P160018, FDA-2016-M-4459............... Foundation Medicine, Inc.. FoundationFocusTM CDxBRACA 12/19/2016
Assay.
P120005/S041, FDA-2016-M-4483.......... Dexcom, Inc............... Dexcom G5 Mobile Continuous 12/20/2016
Glucose Monitoring System.
P040020/S049, FDA-2016-M-4657.......... Alcon Laboratories, Inc... Acrysof[supreg] IQ 12/22/2016
ReSTOR[supreg] +3.0 D
Multifocal Toric Intraocular
Lens.
P160019, FDA-2016-M-4530............... Roche Diagnostics......... Elecsys HBsAg II/Elecsys HBsAg 12/23/2016
Confirmatory Test/
PreciControl HBsAg II.
P100022/S020, FDA-2016-M-4653.......... Cook Medical Inc.......... Zilver PTX Drug-Eluting 12/28/2016
Peripheral Stent.
H070005, FDA-2017-M-0180............... AGA Medical Corp.......... AMPLATZERTM Post-Infarct 1/10/2017
Muscular VSD Occluder.
P160031, FDA-2017-M-0181............... FUJIFILM Medical Systems ASPIRE Cristalle Digital 1/10/2017
U.S.A., Inc. Breast Tomosynthesis Option.
P160008, FDA-2017-M-0229............... HeartSine Technologies LLC HeartSine samaritan[supreg] 1/12/2017
SAM 350P, SAM 360P, and SAM
450P Public Access Automated
External Defibrillators,
Accessories and Saver
EVO[supreg] Software Version
1.4.0.
P160021, FDA-2017-M-0560............... W.L. Gore & Associates, Gore[supreg] Viabahn[supreg] 1/27/2017
Inc. VBX Balloon Expandable
Endoprosthesis.
P130024/S009, FDA-2017-M-0831.......... Lutonix, Inc.............. Lutonix[supreg] 035 Drug 2/7/2017
Coated Balloon PTA Catheter.
P140033, FDA-2017-M-0661............... St. Jude Medical, Inc..... MR Conditional Pacemaker 1/31/2017
System--Assurity MRITM and
Endurity MRITM Pacemakers and
Tendril MRITM 1200M LPA Lead.
P160023, FDA-2017-M-0971............... Hologic, Inc.............. Aptima[supreg] HCV Quant Dx 2/13/2017
Assay.
[[Page 44628]]
P160003, FDA-2016-M-2652............... Biotronik, Inc............ PRO-Kinetic Energy Cobalt 2/14/2017
Chromium Coronary Stent
System.
P150039, FDA-2017-M-1121............... Tryton Medical, Inc....... TRYTON Side Branch Stent...... 2/21/2017
P160014, FDA-2017-M-1122............... CeloNova BioSciences, Inc. COBRA PzFTM NanoCoated 2/21/2017
Coronary Stent System.
P100044/S023, FDA-2017-M-1228.......... Intersect ENT............. PROPEL[supreg] Contour Sinus 2/23/2017
Implant.
P140017/S005, FDA-2017-M-1227.......... Medtronic, Inc............ MelodyTM Transcatheter 2/24/2017
Pulmonary Valve, EnsembleTM
Transcatheter Valve Delivery
System and EnsembleTM II
Transcatheter Valve Delivery
System.
P160016, FDA-2017-M-1713............... Siemens Healthcare VERSANT[supreg] HCV GENOTYPE 3/14/2017
Diagnostics, Inc. 2.0 Assay (LiPA).
P110033/S020, FDA-2017-M-1714.......... Allergan.................. Juv[eacute]derm VollureTM XC.. 3/17/2017
P160025, FDA-2017-M-1845............... Biotronik, Inc............ Astron Pulsar and Pulsar-18 3/23/2017
Stent Systems.
P160009, FDA-2017-M-1950............... iCAD, Inc................. PowerLook[supreg] Tomo 3/24/2017
Detection Software.
P160024, FDA-2017-M-2594............... Bard Peripheral Vascular, LifeStream Balloon Expandable 4/24/2017
Inc. Vascular Covered Stent.
P160043, FDA-2017-M-2767............... Medtronic, Inc............ Resolute Onyx Zotarolimus- 4/28/2017
Eluting Coronary Stent System.
P160040, FDA-2017-M-2766............... Invivoscribe Technologies, LeukoStrat[supreg] CDx FLT3 4/28/2017
Inc. Mutation Assay.
P160046, FDA-2017-M-2768............... Ventana Medical Systems, VENTANA PD-L1 (SP263) Assay... 5/1/2017
Inc.
H150003, FDA-2017-M-3103............... Wilson-Cook Medical, Inc.. FlourishTM Pediatric 5/12/2017
Esophageal Atresia Device.
P160044, FDA-2017-M-3200............... Abbott Molecular, Inc..... Abbott RealTime CMV........... 5/18/2017
P160041, FDA-2017-M-3430............... Roche Molecular Systems, cobas[supreg] CMV............. 6/1/2017
Inc.
P140031/S028, FDA-2017-M-3579.......... Edwards Lifesciences LLC.. Edwards SAPIEN 3TM 6/5/2017
Transcatheter Heart Valve and
Accessories.
P160035, FDA-2017-M-3580............... Berlin Heart, Inc......... EXCOR[supreg] Pediatric 6/6/2017
Ventricular Assist Device.
P160047, FDA-2017-M-3778............... AEGEA Medical, Inc........ AEGEA Vapor SystemTM.......... 6/14/2017
H160002, FDA-2017-M-3839............... Pulsar Vascular, Inc...... PulseRider[supreg] Aneurysm 6/19/2017
Neck Reconstruction Device
(``PulseRider'').
P160045, FDA-2017-M-3928............... Life Technologies Corp.... OncomineTM Dx Target Test..... 6/22/2017
P150046, FDA-2017-M-3982............... SciBase AB................ Nevisense..................... 6/28/2017
P150048, FDA-2017-M-3990............... Edwards Lifesciences, LLC. Edwards Pericardial Aortic 6/29/2017
Bioprosthesis and Edwards
INSPIRIS RESILIA Aortic Valve.
P160038, FDA-2017-M-3983............... Illumina, Inc............. PraxisTM Extended RAS Panel... 6/29/2017
----------------------------------------------------------------------------------------------------------------
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: September 12, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-20391 Filed 9-22-17; 8:45 am]
BILLING CODE 4164-01-P
