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

Federal Register, Volume 77 Issue 193 (Thursday, October 4, 2012)

Federal Register Volume 77, Number 193 (Thursday, October 4, 2012)

Notices

Pages 60704-60705

From the Federal Register Online via the Government Printing Office www.gpo.gov

FR Doc No: 2012-24479

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Docket Nos. FDA-2012-M-0371, FDA-2012-M-0372, FDA-2012-M-0373, FDA-

2012-M-0390, FDA-2012-M-0407, FDA-2012-M-0562, and FDA-2012-M-0638

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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

Page 60705

Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 1650, Silver Spring, MD 20993-0002, 301-796-6570.

SUPPLEMENTARY INFORMATION:

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 April 1, 2012, through June 30, 2012. 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 April 1, 2012, Through

   June 30, 2012

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

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   P020018/S040, FDA-2012-M-0371..... Cook, Inc............ Zenithsupreg Fenestrated April 4, 2012.

   AAA Endovascular Graft

   (with the adjunctive

   Zenith Alignment Stent).

   P110029, FDA-2012-M-0372.......... Abbot Laboratories... ARCHITECT HBsAg April 12, 2012.

   Qualitative, ARCHITECT

   HBsAg Qualitative

   Confirmatory, ARCHITECT

   HBsAg Qualitative

   Confirmatory Manual

   Diluent, ARCHITECT HBsAg

   Qualitative Calibrators,

   and ARCHITECT HBsAg

   Qualitative Controls.

   P110004, FDA-2012-M-0407.......... Medinol Ltd.......... Presillion\TM\ plus CoCr April 12, 2012.

   Coronary Stent on RX

   System.

   P110035, FDA-2012-M-0373.......... Boston Scientific Epic\TM\ Vascular Self- April 13, 2012.

   Corp. Expanding Stent System.

   P090015, FDA-2012-M-0390.......... Leica Biosystems..... BOND\TM\ ORACLE\TM\ HER2 April 18, 2012.

   IHC System.

   P110010/S001, FDA-2012-M-0562..... Boston Scientific PROMUSsupreg Element\TM\ June 1, 2012.

   Corp. Plus Everolimus-Eluting

   Platinum Chromium

   Coronary Stent System

   (Monorail\TM\ and Over-

   the-Wire).

   P090026, FDA-2012-M-0638.......... Beckman Coulter, Inc. Accesssupreg June 14, 2012.

   Hybritechsupreg p2PSA

   on the Access Immunoassay

   Systems.

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2. 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 28, 2012.

   Leslie Kux,

   Assistant Commissioner for Policy.

   FR Doc. 2012-24479 Filed 10-3-12; 8:45 am

   BILLING CODE 4160-01-P