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




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.


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ADDRESSES: Back to Top

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 Back to Top

In accordance with section 515(d)(4) and (e)(2) of the Federal Food, Drug, and Cosmetic Act (the FD 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 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 Back to Top
PMA No., Docket No. Applicant Trade name Approval date
P110003, 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 Back to Top

Dated: March 12, 2012.

Leslie Kux,

Acting Assistant Commissioner for Policy.

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


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