Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications

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

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

date

P130018, FDA-2015-M-4474

Uromedica, Inc

ProACT

TM

Adjustable Continence Therapy for Men

11/24/15

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 Implant

7/1/2016

P150023, FDA-2016-M-1914

Abbott Vascular

Absorb GT1

TM

Bioresorbable Vascular Scaffold (BVS) System

7/5/2016

P100020/S017, FDA-2016-M-1917

Roche Molecular Systems, Inc

cobas® HPV Test

7/7/2016

P090029/S003, FDA-2016-M-2182

Medtronic Sofamor Danek USA, Inc

Prestige LP

TM

Cervical Disc

7/7/2016

P150038, FDA-2016-M-2183

InSightec, Inc

ExAblate Model 4000 Type 1.0 System (ExAblate Neuro)

7/11/2016

P980040/S065, FDA-2016-M-2184

Abbott Medical Optics, Inc

TECNIS® Symfony Extended Range of Vision Intraocular Lens

7/15/2016

P150006, FDA-2016-M-2185

Vasorum, Ltd

Celt ACD Vascular Closure Device

7/20/2016

P160004, FDA-2016-M-2332

W.L. Gore & Associates, Inc

Gore TIGRIS Vascular Stent

7/27/2016

P150003/S003, FDA-2016-M-2334

Boston Scientific Corp

SYNERGY

TM

Everolimus-Eluting Platinum Chromium Coronary Stent System (Over-The-Wire & Monorail)

7/29/2016

P150037, FDA-2016-M-2333

Alcon Laboratories, Inc

CyPass® System (Model 241-S)

7/29/2016

P150001, FDA-2016-M-2500

Medtronic MiniMed

MiniMed 630G System with SmartGuard

8/10/2016

P150036, FDA-2016-M-2485

Edwards Lifesciences, LLC

Edwards INTUITY Elite Valve System

8/12/2016

P130009/S057, FDA-2016-M-2498

Edwards Lifesciences LLC

Edwards SAPIEN XT Transcatheter Heart Valve

8/18/2016

P140031/S010, FDA-2016-M-2499

Edwards Lifesciences LLC

Edwards SAPIEN 3 Transcatheter Heart Valve

8/18/2016

P020045/S073, 2016-M-2649

Medtronic, Inc

Freezor®

Xtra

Cardiac Cryoablation Catheter

8/31/2016

P140010/S015, FDA-2016-M-2650

Medtronic Vascular, Inc

In Pact

TM

Admiral

TM

Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter

9/7/2016

P160001, FDA-2016-M-2651

Obalon Therapeutics, Inc

Obalon Balloon System

9/8/2016

P150040, FDA-2016-M-2735

Carl Zeiss Meditec, Inc

VisuMax® Femtosecond Laser

9/13/2016

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 Glucose Monitoring System

9/23/2016

P080020/S020, FDA-2016-M-2975

Seikagaku Corp

Gel-One®

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, Inc

cobas® EGFR Mutation Test v2

9/28/2016

P150030, FDA-2016-M-3430

Smith & Nephew, Inc

R3

TM

delta Ceramic Acetabular System

10/17/2016

P160006, FDA-2016-M-3431

Ventana Medical Systems, Inc

VENTANA PD-L1 (SP142) Assay

10/18/2016

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

Amplatzer

TM

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 System and iDesign Advanced WaveScan Studio

11/14/2016

P020050/S023, FDA-2016-M-4046

Alcon Laboratories, Inc

WaveLight® EX500 and ALLEGRETTO WAVE® EYE-Q Excimer Laser Systems

11/21/2016

P140029, FDA-2016-M-4344

Q-Med AB

Restylane® Refyne and Restylane® Defyne

12/9/2016

P130007/S016, FDA-2016-M-4458

Animas Corporation

OneTouch Vibe

TM

Plus System

12/16/2016

P160018, FDA-2016-M-4459

Foundation Medicine, Inc

FoundationFocus

TM

CDx

BRACA

Assay

12/19/2016

P120005/S041, FDA-2016-M-4483

Dexcom, Inc

Dexcom G5 Mobile Continuous Glucose Monitoring System

12/20/2016

P040020/S049, FDA-2016-M-4657

Alcon Laboratories, Inc

Acrysof® IQ ReSTOR® +3.0 D Multifocal Toric Intraocular Lens

12/22/2016

P160019, FDA-2016-M-4530

Roche Diagnostics

Elecsys HBsAg II/Elecsys HBsAg Confirmatory Test/PreciControl HBsAg II

12/23/2016

P100022/S020, FDA-2016-M-4653

Cook Medical Inc

Zilver PTX Drug-Eluting Peripheral Stent

12/28/2016

H070005, FDA-2017-M-0180

AGA Medical Corp

AMPLATZER

TM

Post-Infarct Muscular VSD Occluder

1/10/2017

P160031, FDA-2017-M-0181

FUJIFILM Medical Systems U.S.A., Inc

ASPIRE Cristalle Digital Breast Tomosynthesis Option

1/10/2017

P160008, 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

1/12/2017

P160021, FDA-2017-M-0560

W.L. Gore & Associates, Inc

Gore® Viabahn® VBX Balloon Expandable Endoprosthesis

1/27/2017

P130024/S009, FDA-2017-M-0831

Lutonix, Inc

Lutonix® 035 Drug Coated Balloon PTA Catheter

2/7/2017

P140033, 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

1/31/2017

P160023, FDA-2017-M-0971

Hologic, Inc

Aptima® HCV Quant Dx Assay

2/13/2017

P160003, FDA-2016-M-2652

Biotronik, Inc

PRO-Kinetic Energy Cobalt Chromium Coronary Stent System

2/14/2017

P150039, FDA-2017-M-1121

Tryton Medical, Inc

TRYTON Side Branch Stent

2/21/2017

P160014, FDA-2017-M-1122

CeloNova BioSciences, Inc

COBRA PzF

TM

NanoCoated Coronary Stent System

2/21/2017

P100044/S023, FDA-2017-M-1228

Intersect ENT

PROPEL® Contour Sinus Implant

2/23/2017

P140017/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

2/24/2017

P160016, FDA-2017-M-1713

Siemens Healthcare Diagnostics, Inc

VERSANT® HCV GENOTYPE 2.0 Assay (LiPA)

3/14/2017

P110033/S020, FDA-2017-M-1714

Allergan

Juvéderm Vollure

TM

XC

3/17/2017

P160025, FDA-2017-M-1845

Biotronik, Inc

Astron Pulsar and Pulsar-18 Stent Systems

3/23/2017

P160009, FDA-2017-M-1950

iCAD, Inc

PowerLook® Tomo Detection Software

3/24/2017

P160024, FDA-2017-M-2594

Bard Peripheral Vascular, Inc

LifeStream Balloon Expandable Vascular Covered Stent

4/24/2017

P160043, FDA-2017-M-2767

Medtronic, Inc

Resolute Onyx Zotarolimus- Eluting Coronary Stent System

4/28/2017

P160040, FDA-2017-M-2766

Invivoscribe Technologies, Inc

LeukoStrat® CDx FLT3 Mutation Assay

4/28/2017

P160046, FDA-2017-M-2768

Ventana Medical Systems, Inc

VENTANA PD-L1 (SP263) Assay

5/1/2017

H150003, FDA-2017-M-3103

Wilson-Cook Medical, Inc

Flourish

TM

Pediatric Esophageal Atresia Device

5/12/2017

P160044, FDA-2017-M-3200

Abbott Molecular, Inc

Abbott RealTime CMV

5/18/2017

P160041, FDA-2017-M-3430

Roche Molecular Systems, Inc

cobas® CMV

6/1/2017

P140031/S028, FDA-2017-M-3579

Edwards Lifesciences LLC

Edwards SAPIEN 3

TM

Transcatheter Heart Valve and Accessories

6/5/2017

P160035, FDA-2017-M-3580

Berlin Heart, Inc

EXCOR® Pediatric Ventricular Assist Device

6/6/2017

P160047, FDA-2017-M-3778

AEGEA Medical, Inc

AEGEA Vapor System

TM

6/14/2017

H160002, FDA-2017-M-3839

Pulsar Vascular, Inc

PulseRider® Aneurysm Neck Reconstruction Device (“PulseRider”)

6/19/2017

P160045, FDA-2017-M-3928

Life Technologies Corp

Oncomine

TM

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 Bioprosthesis and Edwards INSPIRIS RESILIA Aortic Valve

6/29/2017

P160038, 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]

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