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

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Information about this document as published in the Federal Register.

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This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.




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 section 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 October 1, 2011, through December 31, 2011. 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 October 1, 2011, Through December 31, 2011

PMA No., Docket No.ApplicantTrade nameApproval date
P110003, FDA-2011-M-0746Pluromed, IncLEGOOSeptember 28, 2011.
P090024, FDA-2011-M-0737Siemens Healthcare DiagnosticsADVIA CENTAUR HBEAG assay and quality control materialOctober 11, 2011.
P040024 (S51), FDA-2011-M-0735Medicis Aesthetics, IncRESTYLANE injectable gelOctober 11, 2011.
P010029 (S8), FDA-2011-M-0736Ferring Pharmaceuticals, IncEUFLEXXA (1% sodium hyaluronate)October 11, 2011.
P110022, FDA-2011-M-0786Roche Diagnostics CorpELECSYS anti-HBC IGM immunoassay and ELECSYS PRECICONTROL anti-HBC IGMOctober 26, 2011.
P110011, FDA-2011-M-0791Medtronic IrelandASSURANT COBALT iliac balloon-expandable stent systemOctober 26, 2011.
P100042, FDA-2011-M-0792Gen-Probe IncorporatedAPTIMA HPV assayOctober 28, 2011.
P110019, FDA-2011-M-0796Abbott VascularXIENCE PRIME and XIENCE PRIME LL EVEROLIMUS-eluting coronary stent systemNovember 1, 2011.
P100041, FDA-2011-M-0837Edwards Lifesciences, LLCEDWARDS SAPIEN transcatheter heart valve and RETROFLEX 3 delivery system, RETROFLEX balloon catheter and crimperNovember 2, 2011.
P090016, FDA-2011-M-0832Merz Aesthetics, IncBELOTERO balanceNovember 14, 2011.
H090002, FDA-2011-M-0848BSD Medical CorpBSD-2000 hyperthermia systemNovember 18, 2011.
P110010, FDA-2011-M-0865Boston Scientific CorpPROMUS ELEMENT PLUS EVEROLIMUS-eluting platinum chromium coronary stent systemNovember 22, 2011.
P100024, FDA-2011-M-0866Dako Denmark A/SHER2 CISH PHARMDX kitNovember 30, 2011.
P110025, FDA-2011-M-0917Roche Diagnostics CorpELECSYS anti-HBC IGM immunoassay and ELECSYS PRECICONTROL anti-HBC IGM for use on the MODULAR ANALYTICS E170 immunoassay analyzeDecember 14, 2011.
P100046, FDA-2011-M-0910AtriCure IncATRICURE SYNERGY ablation systemDecember 14, 2011.

II. Electronic Access

Persons with access to the Internet may obtain the documents at:; and

Dated: March 12, 2012.

Leslie Kux,

Acting Assistant Commissioner for Policy.

[FR Doc. 2012-6390 Filed 3-15-12; 8:45 am]