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 Department of Health and Human Services Food and Drug Administration [Docket Nos. FDA-2011-M-0735, FDA-2011-M-0736, FDA-2011-M-0737, FDA-2011-M-0746, FDA-2011-M-0786, FDA-2011-M-0791, FDA-2011-M-0792, FDA-2011-M-0796, FDA-2011-M-0832, FDA-2011-M-0837, FDA-2011-M-0848, FDA-2011-M-0865, FDA-2011-M-0866, FDA-2011-M-0910, and FDA-2011-M-0917]
 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, 301-796-6570.


SUPPLEMENTARY INFORMATION: 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.
Applicant
Trade name
Approval dateP110003, FDA-2011-M-0746
Pluromed, Inc
LEGOO
September 28, 2011.P090024, FDA-2011-M-0737
Siemens Healthcare Diagnostics
ADVIA CENTAUR HBEAG assay and quality control material
October 11, 2011.P040024 (S51), FDA-2011-M-0735
Medicis Aesthetics, Inc
RESTYLANE injectable gel
October 11, 2011.P010029 (S8), FDA-2011-M-0736
Ferring Pharmaceuticals, Inc
EUFLEXXA (1% sodium hyaluronate)
October 11, 2011.P110022, FDA-2011-M-0786
Roche Diagnostics Corp
ELECSYS anti-HBC IGM immunoassay and ELECSYS PRECICONTROL anti-HBC IGM
October 26, 2011.P110011, FDA-2011-M-0791
Medtronic Ireland
ASSURANT COBALT iliac balloon-expandable stent system
October 26, 2011.P100042, FDA-2011-M-0792
Gen-Probe Incorporated
APTIMA HPV assay
October 28, 2011.P110019, FDA-2011-M-0796
Abbott Vascular
XIENCE PRIME and XIENCE PRIME LL EVEROLIMUS-eluting coronary stent system
November 1, 2011.P100041, FDA-2011-M-0837
Edwards Lifesciences, LLC
EDWARDS SAPIEN transcatheter heart valve and RETROFLEX 3 delivery system, RETROFLEX balloon catheter and crimper
November 2, 2011.P090016, FDA-2011-M-0832
Merz Aesthetics, Inc
BELOTERO balance
November 14, 2011.H090002, FDA-2011-M-0848
BSD Medical Corp
BSD-2000 hyperthermia system
November 18, 2011.P110010, FDA-2011-M-0865
Boston Scientific Corp
PROMUS ELEMENT PLUS EVEROLIMUS-eluting platinum chromium coronary stent system
November 22, 2011.P100024, FDA-2011-M-0866
Dako Denmark A/S
*HER2*
                             CISH PHARMDX kit
November 30, 2011.P110025, FDA-2011-M-0917
Roche Diagnostics Corp
ELECSYS anti-HBC IGM immunoassay and ELECSYS PRECICONTROL anti-HBC IGM for use on the MODULAR ANALYTICS E170 immunoassay analyze
December 14, 2011.P100046, FDA-2011-M-0910
AtriCure Inc
ATRICURE SYNERGY ablation system
December 14, 2011.
 II. Electronic Access Persons with access to the Internet may obtain the documents at: *http://www.fda.gov/​MedicalDevices/​ProductsandMedicalProcedures/​DeviceApprovalsandClearances/​PMAApprovals/​default.htm;*
                     and *http://www.fda.gov/​MedicalDevices/​ProductsandMedicalProcedures/​DeviceApprovalsandClearances/​HDEApprovals/​ucm161827.htm.* Dated: March 12, 2012. Leslie Kux, Acting Assistant Commissioner for Policy.


[FR Doc. 2012-6390 Filed 3-15-12; 8:45 am] BILLING CODE 4160-01-P