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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]
 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 
                    ( print 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 § 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
PMA No., Docket No.
Applicant
Trade name
Approval
                             dateP130018, FDA-2015-M-4474
Uromedica, Inc
ProACT
                            TM
                             Adjustable Continence Therapy for Men
11/24/15P140003/S004, FDA-2016-M-1915
Abiomed, Inc
Impella Ventricular Support
4/7/2016P150034, FDA-2016-M-1837
Revision Optics, Inc
Raindrop Near Vision Inlay
6/29/2016P150017, FDA-2016-M-1916
Cartiva, Inc
Cartiva Synthetic Cartilage Implant
7/1/2016P150023, FDA-2016-M-1914
Abbott Vascular
Absorb GT1
                            TM
                             Bioresorbable Vascular Scaffold (BVS) System
7/5/2016P100020/S017, FDA-2016-M-1917
Roche Molecular Systems, Inc
cobas® HPV Test
7/7/2016P090029/S003, FDA-2016-M-2182
Medtronic Sofamor Danek USA, Inc
Prestige LP
                            TM
                             Cervical Disc
7/7/2016P150038, FDA-2016-M-2183
InSightec, Inc
ExAblate Model 4000 Type 1.0 System (ExAblate Neuro)
7/11/2016P980040/S065, FDA-2016-M-2184
Abbott Medical Optics, Inc
TECNIS® Symfony Extended Range of Vision Intraocular Lens
7/15/2016P150006, FDA-2016-M-2185
Vasorum, Ltd
Celt ACD Vascular Closure Device
7/20/2016P160004, FDA-2016-M-2332
W.L. Gore & Associates, Inc
Gore TIGRIS Vascular Stent
7/27/2016P150003/S003, FDA-2016-M-2334
Boston Scientific Corp
SYNERGY
                            TM
                             Everolimus-Eluting Platinum Chromium Coronary Stent System (Over-The-Wire & Monorail)
7/29/2016P150037, FDA-2016-M-2333
Alcon Laboratories, Inc
CyPass® System (Model 241-S)
7/29/2016P150001, FDA-2016-M-2500
Medtronic MiniMed
MiniMed 630G System with SmartGuard
8/10/2016P150036, FDA-2016-M-2485
Edwards Lifesciences, LLC
Edwards INTUITY Elite Valve System
8/12/2016P130009/S057, FDA-2016-M-2498
Edwards Lifesciences LLC
Edwards SAPIEN XT Transcatheter Heart Valve
8/18/2016P140031/S010, FDA-2016-M-2499
Edwards Lifesciences LLC
Edwards SAPIEN 3 Transcatheter Heart Valve
8/18/2016P020045/S073, 2016-M-2649
Medtronic, Inc
Freezor® 
                            *Xtra*
                             Cardiac Cryoablation Catheter
8/31/2016P140010/S015, FDA-2016-M-2650
Medtronic Vascular, Inc
In Pact
                            TM
                             Admiral
                            TM
                             Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter
9/7/2016P160001, FDA-2016-M-2651
Obalon Therapeutics, Inc
Obalon Balloon System
9/8/2016P150040, FDA-2016-M-2735
Carl Zeiss Meditec, Inc
VisuMax® Femtosecond Laser
9/13/2016P000025/S084, FDA-2016-M-2974
MED-EL Corp
MED-EL Cochlear Implant System
9/15/2016P150021, FDA-2016-M-2971
Abbott Diabetes Care, Inc
Freestyle Libre Pro Flash Glucose Monitoring System
9/23/2016P080020/S020, FDA-2016-M-2975
Seikagaku Corp
Gel-One®
9/27/2016P160017, FDA-2016-M-1972
Medtronic MiniMed, Inc
MiniMed 670G System
9/28/2016P150044, FDA-2016-M-2973
Roche Molecular Systems, Inc
cobas® EGFR Mutation Test v2
9/28/2016P150030, FDA-2016-M-3430
Smith & Nephew, Inc
R3
                            TM
                             delta Ceramic Acetabular System
10/17/2016P160006, FDA-2016-M-3431
Ventana Medical Systems, Inc
VENTANA PD-L1 (SP142) Assay
10/18/2016P150013/S001, FDA-2016-M-3913
Dako North America, Inc
PD-L1 IHC 22C3 pharmDX
10/24/2016P120021, FDA-2016-M-3653
St. Jude Medical, Inc
Amplatzer
                            TM
                             PFO Occluder
10/28/2016P150043, FDA-2016-M-3914
QView Medical, Inc
QVCAD System
11/9/2016P930016/S045, FDA-2016-M-3915
AMO Manufacturing USA, LLC
Star S4 IR Excimer Laser System and iDesign Advanced WaveScan Studio
11/14/2016P020050/S023, FDA-2016-M-4046
Alcon Laboratories, Inc
WaveLight® EX500 and ALLEGRETTO WAVE® EYE-Q Excimer Laser Systems
11/21/2016P140029, FDA-2016-M-4344
Q-Med AB
Restylane® Refyne and Restylane® Defyne
12/9/2016P130007/S016, FDA-2016-M-4458
Animas Corporation
OneTouch Vibe
                            TM
                             Plus System
12/16/2016P160018, FDA-2016-M-4459
Foundation Medicine, Inc
FoundationFocus
                            TM
                             CDx
                            BRACA
                             Assay
12/19/2016P120005/S041, FDA-2016-M-4483
Dexcom, Inc
Dexcom G5 Mobile Continuous Glucose Monitoring System
12/20/2016P040020/S049, FDA-2016-M-4657
Alcon Laboratories, Inc
Acrysof® IQ ReSTOR® +3.0 D Multifocal Toric Intraocular Lens
12/22/2016P160019, FDA-2016-M-4530
Roche Diagnostics
Elecsys HBsAg II/Elecsys HBsAg Confirmatory Test/PreciControl HBsAg II
12/23/2016P100022/S020, FDA-2016-M-4653
Cook Medical Inc
Zilver PTX Drug-Eluting Peripheral Stent
12/28/2016H070005, FDA-2017-M-0180
AGA Medical Corp
AMPLATZER
                            TM
                             Post-Infarct Muscular VSD Occluder
1/10/2017P160031, FDA-2017-M-0181
FUJIFILM Medical Systems U.S.A., Inc
ASPIRE Cristalle Digital Breast Tomosynthesis Option
1/10/2017P160008, FDA-2017-M-0229
HeartSine Technologies LLC
HeartSine samaritan® SAM 350P, SAM 360P, and SAM 450P Public Access Automated External Defibrillators, Accessories and Saver EVO® Software Version 1.4.0
1/12/2017P160021, FDA-2017-M-0560
W.L. Gore & Associates, Inc
Gore® Viabahn® VBX Balloon Expandable Endoprosthesis
1/27/2017P130024/S009, FDA-2017-M-0831
Lutonix, Inc
Lutonix® 035 Drug Coated Balloon PTA Catheter
2/7/2017P140033, FDA-2017-M-0661
St. Jude Medical, Inc
MR Conditional Pacemaker System—Assurity MRI
                            TM
                             and Endurity MRI
                            TM
                             Pacemakers and Tendril MRI
                            TM
                             1200M LPA Lead
1/31/2017P160023, FDA-2017-M-0971
Hologic, Inc
Aptima® HCV Quant Dx Assay
2/13/2017( print page 44628)P160003, FDA-2016-M-2652
Biotronik, Inc
PRO-Kinetic Energy Cobalt Chromium Coronary Stent System
2/14/2017P150039, FDA-2017-M-1121
Tryton Medical, Inc
TRYTON Side Branch Stent
2/21/2017P160014, FDA-2017-M-1122
CeloNova BioSciences, Inc
COBRA PzF
                            TM
                             NanoCoated Coronary Stent System
2/21/2017P100044/S023, FDA-2017-M-1228
Intersect ENT
PROPEL® Contour Sinus Implant
2/23/2017P140017/S005, FDA-2017-M-1227
Medtronic, Inc
Melody
                            TM
                             Transcatheter Pulmonary Valve, Ensemble
                            TM
                             Transcatheter Valve Delivery System and Ensemble
                            TM
                             II Transcatheter Valve Delivery System
2/24/2017P160016, FDA-2017-M-1713
Siemens Healthcare Diagnostics, Inc
VERSANT® HCV GENOTYPE 2.0 Assay (LiPA)
3/14/2017P110033/S020, FDA-2017-M-1714
Allergan
Juvéderm Vollure
                            TM
                             XC
3/17/2017P160025, FDA-2017-M-1845
Biotronik, Inc
Astron Pulsar and Pulsar-18 Stent Systems
3/23/2017P160009, FDA-2017-M-1950
iCAD, Inc
PowerLook® Tomo Detection Software
3/24/2017P160024, FDA-2017-M-2594
Bard Peripheral Vascular, Inc
LifeStream Balloon Expandable Vascular Covered Stent
4/24/2017P160043, FDA-2017-M-2767
Medtronic, Inc
Resolute Onyx Zotarolimus- Eluting Coronary Stent System
4/28/2017P160040, FDA-2017-M-2766
Invivoscribe Technologies, Inc
LeukoStrat® CDx FLT3 Mutation Assay
4/28/2017P160046, FDA-2017-M-2768
Ventana Medical Systems, Inc
VENTANA PD-L1 (SP263) Assay
5/1/2017H150003, FDA-2017-M-3103
Wilson-Cook Medical, Inc
Flourish
                            TM
                             Pediatric Esophageal Atresia Device
5/12/2017P160044, FDA-2017-M-3200
Abbott Molecular, Inc
Abbott RealTime CMV
5/18/2017P160041, FDA-2017-M-3430
Roche Molecular Systems, Inc
cobas® CMV
6/1/2017P140031/S028, FDA-2017-M-3579
Edwards Lifesciences LLC
Edwards SAPIEN 3
                            TM
                             Transcatheter Heart Valve and Accessories
6/5/2017P160035, FDA-2017-M-3580
Berlin Heart, Inc
EXCOR® Pediatric Ventricular Assist Device
6/6/2017P160047, FDA-2017-M-3778
AEGEA Medical, Inc
AEGEA Vapor System
                            TM
6/14/2017H160002, FDA-2017-M-3839
Pulsar Vascular, Inc
PulseRider® Aneurysm Neck Reconstruction Device (“PulseRider”)
6/19/2017P160045, FDA-2017-M-3928
Life Technologies Corp
Oncomine
                            TM
                             Dx Target Test
6/22/2017P150046, FDA-2017-M-3982
SciBase AB
Nevisense
6/28/2017P150048, FDA-2017-M-3990
Edwards Lifesciences, LLC
Edwards Pericardial Aortic Bioprosthesis and Edwards INSPIRIS RESILIA Aortic Valve
6/29/2017P160038, FDA-2017-M-3983
Illumina, Inc
Praxis
                            TM
                             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