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

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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.


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.


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.


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. 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, 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

PMA No., Docket No.ApplicantTrade nameApproval date
P020018/S040, FDA-2012-M-0371Cook, IncZenith® Fenestrated AAA Endovascular Graft (with the adjunctive Zenith Alignment Stent)April 4, 2012.
P110029, FDA-2012-M-0372Abbot LaboratoriesARCHITECT HBsAg Qualitative, ARCHITECT HBsAg Qualitative Confirmatory, ARCHITECT HBsAg Qualitative Confirmatory Manual Diluent, ARCHITECT HBsAg Qualitative Calibrators, and ARCHITECT HBsAg Qualitative ControlsApril 12, 2012.
P110004, FDA-2012-M-0407Medinol Ltd.PresillionTM plus CoCr Coronary Stent on RX SystemApril 12, 2012.
P110035, FDA-2012-M-0373Boston Scientific CorpEpicTM Vascular Self-Expanding Stent SystemApril 13, 2012.
P090015, FDA-2012-M-0390Leica BiosystemsBONDTM ORACLETM HER2 IHC SystemApril 18, 2012.
P110010/S001, FDA-2012-M-0562Boston Scientific CorpPROMUS® ElementTM Plus Everolimus-Eluting Platinum Chromium Coronary Stent System (MonorailTM and Over-the-Wire)June 1, 2012.
P090026, FDA-2012-M-0638Beckman Coulter, IncAccess® Hybritech® p2PSA on the Access Immunoassay SystemsJune 14, 2012.

II. Electronic Access

Persons with access to the Internet may obtain the documents at

Dated: September 28, 2012.

Leslie Kux,

Assistant Commissioner for Policy.

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