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

---
identifier: "/us/fr/2018-10924"
source: "fr"
legal_status: "authoritative_unofficial"
title: "Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications"
title_number: 0
title_name: "Federal Register"
section_number: "2018-10924"
section_name: "Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications"
positive_law: false
currency: "2018-05-22"
last_updated: "2018-05-22"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "2018-10924"
document_type: "notice"
publication_date: "2018-05-22"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
fr_citation: "83 FR 23686"
fr_volume: 83
docket_ids:
  - "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-2"
fr_action: "Notice."
---


#  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.

| 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
                            
                             System, Medtronic CoreValve
                            
                             Evolut
                            
                             R System and Medtronic CoreValve
                            
                             Evolut
                            
                             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
                            
                             Bioprosthesis | 7/31/2017 |
| P170005, FDA-2017-M-4757 | Abbott Molecular, Inc | Abbott RealTi
                            
                            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
                            
                             Spinal Cord Stimulator System, Precision Spectra
                            
                             Spinal Cord Stimulator System, Precision
                            
                             Novi
                            
                             Spinal Cord Stimulator System, Precision
                            
                             Montage
                            
                             MRI Spinal Cord Stimulator System, Precision
                            
                             Montage
                            
                             Spinal Cord Stimulator System and Spectra WaveWriter
                            
                             Spinal Cord Stimulator System | 8/11/2017 |
| P160054, FDA-2017-M-5320 | Thoratec Corporation | HeartMate 3
                            
                             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
                            
                             HVAD
                            
                             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
                            
                             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
                            
                             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
                            
                             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.