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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.
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 theSUPPLEMENTARY INFORMATIONsection for electronic access to the summaries of safety and effectiveness.
FOR FURTHER INFORMATION CONTACT: Nicole Wolanski, Center for Devices and Radiological Health, Food and DrugAdministration, 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. 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. Applicant Trade name Approval date P020018/S040, FDA-2012-M-0371 Cook, Inc Zenith® Fenestrated AAA Endovascular Graft (with the adjunctive Zenith Alignment Stent) April 4, 2012. P110029, FDA-2012-M-0372 Abbot Laboratories ARCHITECT HBsAg Qualitative, ARCHITECT HBsAg Qualitative Confirmatory, ARCHITECT HBsAg Qualitative Confirmatory Manual Diluent, ARCHITECT HBsAg Qualitative Calibrators, and ARCHITECT HBsAg Qualitative Controls April 12, 2012. P110004, FDA-2012-M-0407 Medinol Ltd. PresillionTM plusCoCr Coronary Stent on RX System April 12, 2012. P110035, FDA-2012-M-0373 Boston Scientific Corp EpicTMVascular Self-Expanding Stent System April 13, 2012. P090015, FDA-2012-M-0390 Leica Biosystems BONDTMORACLETMHER2 IHC System April 18, 2012. P110010/S001, FDA-2012-M-0562 Boston Scientific Corp PROMUS® ElementTMPlus Everolimus-Eluting Platinum Chromium Coronary Stent System (MonorailTMand Over-the-Wire) June 1, 2012. P090026, FDA-2012-M-0638 Beckman Coulter, Inc Access® Hybritech® p2PSA on the Access Immunoassay Systems June 14, 2012. II. Electronic Access

Persons with access to the Internet may obtain the documents athttp://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/PMAApprovals/default.htm.

Dated: September 28, 2012. Leslie Kux, Assistant Commissioner for Policy.