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


Federal Register, Volume 78 Issue 113 (Wednesday, June 12, 2013)

Federal Register Volume 78, Number 113 (Wednesday, June 12, 2013)


Page 35284

From the Federal Register Online via the Government Printing Office

FR Doc No: 2013-13905



Food and Drug Administration

Docket Nos. FDA-2013-M-0036, FDA-2013-M-0205, FDA-2013-M-0255, FDA-

2013-M-0281, FDA-2013-M-0282, and FDA-2013-M-0343

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 of this document 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-



  1. 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. The 30-day period for requesting reconsideration of an FDA action under Sec. 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 January 1, 2013, through March 31, 2013. 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 January 1, 2013,

    Through March 31, 2013


    PMA No., docket No. Applicant Trade name Approval date


    P110014, FDA-2013-M-0036.......... Dune Medical Devices, MarginProbe System... December 27, 2012.


    H110002, FDA-2013-M-0205.......... Second Sight Medical ArgusTM II Retinal February 13, 2013.

    Products, Inc. Prosthesis System.

    P110032, FDA-2013-M-0282.......... Lombard Medical...... Aorfix AAA Flexible February 14, 2013.

    Stent Graft System.

    P040046, FDA-2013-M-0255.......... Allergan............. Natrellesupreg 410 February 20, 2013.

    Highly Cohesive

    Anatomically Shaped


    Breast Implants.

    P110013/S005, FDA-2013-M-0343..... Medtronic Vascular, Resolute Integrity February 22, 2013.

    Inc. Zotarolimus-Eluting

    Coronary Stent


    P100030, FDA-2013-M-0281.......... Tenaxis Medical, Inc. ArterX Surgical March 1, 2013.



  2. Electronic Access

    Persons with access to the Internet may obtain the documents at

    Dated: June 7, 2013.

    Leslie Kux,

    Assistant Commissioner for Policy.

    FR Doc. 2013-13905 Filed 6-11-13; 8:45 am

    BILLING CODE 4160-01-P