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-2017-M-3372, FDA-2017-M-3951, FDA-2017-M-3990, FDA-2017-M-4022, FDA-2017-M-4271, FDA-2017-M-4498, FDA-2017-M-4756, FDA-2017-M-4757, FDA-2017-M-4711, FDA-2017-M-4904, FDA-2017-M-5320, FDA-2017-M-5262, FDA-2017-M-5334, FDA-2017-M-5438, FDA-2017-M-5813, FDA-2017-M-5863, FDA-2017-M-5864, FDA-2017-M-5884, FDA-2017-M-5929, FDA-2017-M-5969, FDA-2017-M-5968, FDA-2017-M-5997, FDA-2017-M-6223, FDA-2017-M-6232, FDA-2017-M-6290, FDA-2017-M-6524, FDA-2017-M-6525, FDA-2017-M-6550, FDA-2017-M-6614, FDA-2017-M-6650, FDA-2017-M-6799, FDA-2017-M-6800, and FDA-2017-M-6896]

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

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the internet and the Agency's Dockets Management Staff.

ADDRESSES:

You may submit comments as follows:

Electronic Submissions

Submit electronic comments in the following way:

•

Federal eRulemaking Portal: httpss://www.regulations.gov

. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to

https://www.regulations.gov

will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on

https://www.regulations.gov

.

• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions

Submit written/paper submissions as follows:

•

Mail/Hand delivery/Courier (for written/paper submissions):

Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

Instructions:

All submissions received must include the Docket Nos. FDA-2017-M-3372, FDA-2017-M-3951, FDA-2017-M-3990, FDA-2017-M-4022, FDA-2017-M-4271, FDA-2017-M-4498, FDA-2017-M-4756, FDA-2017-M-4757, FDA-2017-M-4711, FDA-2017-M-4904, FDA-2017-M-5320, FDA-2017-M-5262, FDA-2017-M-5334, FDA-2017-M-5438, FDA-2017-M-5813, FDA-2017-M-5863, FDA-2017-M-5864, FDA-2017-M-5884, FDA-2017-M-5929, FDA-2017-M-5969, FDA-2017-M-5968, FDA-2017-M-5997, FDA-2017-M-6223, FDA-2017-M-6232, FDA-2017-M-6290, FDA-2017-M-6524, FDA-2017-M-6525, FDA-2017-M-6550, FDA-2017-M-6614, FDA-2017-M-6650, FDA-2017-M-6799, FDA-2017-M-6800, and FDA-2017-M-6896 for “Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at

https://www.regulations.gov

or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on

https://www.regulations.gov

. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at:

https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf

.

Docket:

For access to the docket to read background documents or the electronic and written/paper comments received, go to

https://www.regulations.gov

and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Joshua Nipper, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1650, Silver Spring, MD 20993-0002, 301-796-6524.

SUPPLEMENTARY INFORMATION:

I. Background

In accordance with section 515(d)(4) and (e)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360e(d)(4) and (e)(2)), notification of an order approving, denying, or withdrawing approval of a PMA will continue to include a notice of opportunity to request review of the order under section 515(g) of the FD&C Act. The 30-day period for requesting reconsideration of an FDA action under § 10.33(b) (21 CFR 10.33(b)) for notices announcing approval of a PMA begins on the day the notice is placed on the internet. Section 10.33(b) provides that FDA may, for good cause, extend this 30-day period. Reconsideration of a denial or withdrawal of approval of a PMA may be sought only by the applicant; in these cases, the 30-day period will begin when the applicant is notified by FDA in writing of its decision.

The regulations provide that FDA publish a list of available safety and effectiveness summaries of PMA approvals and denials that were announced during that quarter. The following is a list of approved PMAs for which summaries of safety and effectiveness were placed on the internet from July 1, 2017, through December 31, 2017. There were no denial actions during this period. The list provides the manufacturer's name, the product's generic name or the trade name, and the approval date.

Table 1—List of Safety and Effectiveness Summaries for Approved PMAs Made Available From July 1, 2017, Through December 31, 2017

PMA No., Docket No.

Applicant

Trade name

Approval date

P160015, FDA-2017-M-3372

Zoll Medical Corporation

AED Plus® and Fully Automatic AED Plus®

5/26/2017

P970003/S207, FDA-2017-M-3951

Cyberonics, Inc

VNS Therapy System

6/23/2017

P150048, FDA-2017-M-3990

Edwards Lifesciences, LLC

Edwards Pericardial Aortic Bioprosthesis and Edwards INSPIRIS RESILIA Aortic Valve

6/29/2017

P930016/S048, FDA-2017-M-4022

AMO Manufacturing USA, LLC

STAR S4 IR Excimer Laser System and iDesign Advanced WaveScan Studio System

6/30/2017

P130021/S033, FDA-2017-M-4271

Medtronic CoreValve LLC

Medtronic CoreValve

TM

System, Medtronic CoreValve

TM

Evolut

TM

R System and Medtronic CoreValve

TM

Evolut

TM

PRO Systems

7/10/2017

P160049, FDA-2017-M-4498

Spectranetics Corp

Stellarex 0.035″ OTW Drug-coated Angioplasty Balloon

7/26/2017

P170006, FDA-2017-M-4756

Medtronic, Inc

Avalus

TM

Bioprosthesis

7/31/2017

P170005, FDA-2017-M-4757

Abbott Molecular, Inc

Abbott RealTi

m

e IDH2

8/1/2017

P160042, FDA-2017-M-4711

Prollenium Medical Technologies, Inc

Ravanesse Ultra

8/4/2017

P030017/S275, FDA-2017-M-4904

Boston Scientific Neuromodulation Corporation

Precision

TM

Spinal Cord Stimulator System, Precision Spectra

TM

Spinal Cord Stimulator System, Precision

TM

Novi

TM

Spinal Cord Stimulator System, Precision

TM

Montage

TM

MRI Spinal Cord Stimulator System, Precision

TM

Montage

TM

Spinal Cord Stimulator System and Spectra WaveWriter

TM

Spinal Cord Stimulator System

8/11/2017

P160054, FDA-2017-M-5320

Thoratec Corporation

HeartMate 3

TM

Left Ventricular Assist System

8/23/2017

P140015/S020, FDA-2017-M-5262

Tandem Diabetes Care, Inc

t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM

8/25/2017

P170003, FDA-2017-M-5334

Lutonix, Inc

Lutonix® 035 Drug Coated Balloon PTA Catheter, Model 9010

8/25/2017

P170007, FDA-2017-M-5438

Bioventus LLC

DUROLANE®

8/29/2017

P150025/S003, FDA-2017-M-5813

Dako North America, Inc

PD-L1 IHC 28-8 pharmDx

9/15/2017

P150042, FDA-2017-M-5863

ZEUS Scientific, Inc

ZEUS ELISA Parvovirus B19 IgM Test System

9/19/2017

P150045, FDA-2017-M-5864

ZEUS Scientific, Inc

ZEUS ELISA Parvovirus B19 IgG Test System

9/19/2017

P170011, FDA-2017-M-5884

ABIOMED, Inc

Impella RP® System

9/20/2017

P150013/S006, FDA-2017-M-5929

Dako North America, Inc

PD-L1 IHC 22C3 pharmDx

9/22/2017

P160030, FDA-2017-M-5969

Abbott Diabetes Care, Inc

Freestyle Libre Flash Glucose Monitoring System

9/27/2017

P100047/S090, FDA-2017-M-5968

Medtronic, Inc

HeartWare

TM

HVAD

TM

System

9/27/2017

P100021/S063, FDA-2017-M-5997

Medtronic Vascular

Endurant II/Endurant IIs Stent Graft System

9/29/2017

P160039, FDA-2017-M-6223

Respicardia, Inc

remedē® System

10/6/2017

P170002, FDA-2017-M-6232

Teoxane S.A

RHA® 2, RHA® 3 and RHA® 4

10/19/2017

P150028/S001, FDA-2017-M-6290

NuMED, Inc

Cheatham Platinum (CP) Stent System (Covered CP Stent, Model 427; Covered Mounted (CP) Stent, Model 428; CP Stent, Model 425; Mounted CP Stent, Model 426)

10/24/2017

H020002/S046, FDA-2017-M-6524

Stryker Neurovascular

Neuroform Atlas

TM

Stent System

11/2/2017

P160057, FDA-2017-M-6525

OrthogenRx, Inc

TriVisc

11/13/2017

P160043/S001, FDA-2017-M-6550

Medtronic Vascular

Resolute Onyx

TM

Zotarolimus-Eluting Coronary Stent System

11/16/2017

P160055, FDA-2017-M-6614

RxSight, Inc

Light Adjustable Lens (LAL) and Light Delivery Device (LDD)

11/22/2017

P170008, FDA-2017-M-6650

Medinol Ltd

EluNIR® Ridaforolimus Eluting Coronary Stent System

11/28/2017

P170019, FDA-2017-M-6799

Foundation Medicine, Inc

FoundationOne CDx

11/30/2017

P150031, FDA-2017-M-6800

Boston Scientific Corporation

Vercise Deep Brain Stimulation (DBS) System

12/8/2017

P170012, FDA-2017-M-6896

Biom'Up SA

HEMOBLAST

TM

Bellows

12/15/2017

II. Electronic Access

Persons with access to the internet may obtain the documents at

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/PMAApprovals/default.htm

.

Dated: May 17, 2018.

Leslie Kux,

Associate Commissioner for Policy.

[FR Doc. 2018-10924 Filed 5-21-18; 8:45 am]

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