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

---
identifier: "/us/fr/2014-22987"
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: "2014-22987"
section_name: "Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications"
positive_law: false
currency: "2014-09-26"
last_updated: "2014-09-26"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "2014-22987"
document_type: "notice"
publication_date: "2014-09-26"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
fr_citation: "79 FR 57940"
fr_volume: 79
docket_ids:
  - "Docket Nos. FDA-2014-M-0327, FDA-2014-M-0434, FDA-2014-M-0552, FDA-2014-M-0553, FDA-2014-M-0690"
  - "FDA-2014-M-0691, FDA-2014-M-0692, FDA-2014-M-0726, FDA-2014-M-0727, FDA-2014-M-0866, and FDA-2014-M-0872"
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 Division of Dockets Management.

**ADDRESSES:**

Submit written requests for copies of summaries of safety and  effectiveness data to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Please cite the appropriate docket number as listed in table 1 when submitting a written request. See the *SUPPLEMENTARY INFORMATION* section for electronic access to the summaries of safety and effectiveness.

**FOR FURTHER INFORMATION CONTACT:**

Nicole Wolanski, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1650, Silver Spring, MD 20993-0002, 301-796-6570.

**SUPPLEMENTARY INFORMATION:**

**I. Background**

In accordance with sections 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 (21 U.S.C. 360e(g)). 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 April 1, 2014, through June 30, 2014. 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 |
| --- | --- | --- | --- |
| P130016, FDA-2014-M-0327 | Cochlear Americas | Nucleus® Hybrid
                            
                             L24 Cochlear Implant System | March 20, 2014. |
| P120020, FDA-2014-M-0434 | Abbott Vascular (IDEV Technologies, Inc.) | SUPERA® Peripheral Stent System | March 28, 2014. |
| P010015/S205, FDA-2014-M-0553 | Medtronic, Inc | Cardiac Resynchronization Therapy Pacemaker (CRT-P) Devices | April 10, 2014. |
| P010031/S381, FDA-2014-M-0553 | Medtronic, Inc | Cardiac Resynchronization Therapy Defibrillator (CRT-D) Devices | April 10, 2014. |
| P100020/S008, FDA-2014-M-0552 | Roche Molecular Systems, Inc | cobas® HPV Test | April 24, 2014. |
| P130008, FDA-2014-M-0690 | Inspire Medical Systems, Inc | Inspire Upper Airway Stimulation (UAS) system | April 30, 2014. |
| P110005, FDA-2014-M-0691 | IBSA Institut Biochimique SA | Gel-Syn
                            
                             Sinovial (Sodium Hyaluronate 0.8%) | May 9, 2014. |
| P110041, FDA-2014-M-0692 | Siemens Healthcare Diagnostics | ADVIA Centaur® HBsAgII, ADVIA Centaur® HBsAg Confirmatory and ADVIA Centaur® HBsAg Quality Control Material | May 16, 2014. |
| P110027, FDA-2014-M-0726 | QIAGEN Manchester Ltd | therascreen® KRAS RGQ PCR Kit | May 23, 2014. |
| P100045, FDA-2014-M-0727 | CardioMEMS, Inc | CardioMEMS
                            
                             HF System | May 28, 2014. |
| P130027, FDA-2014-M-0866 | QIAGEN, Inc | artus® CMV RGQ MDx Kit | June 2, 2014. |
| P040024/S072, FDA-2014-M-0872 | Valeant Pharmaceuticals North America LLC/Medicis | Restylane Silk Injectable Gel | June 13, 2014. |

**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: September 23, 2014

Leslie Kux,

Assistant Commissioner for Policy.