Document ID: FDA-2015-M-4474-0002
Agency: fda
Document Type: Notice
Title: Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
Posted Date: 2017-09-25T04:00Z

[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]

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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.

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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