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.
Table of Contents Back to Top
Tables Back to Top
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.
FOR FURTHER INFORMATION CONTACT: Back to Top
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: Back to Top
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.
|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
Persons with access to the Internet may obtain the documents at:
Dated: March 12, 2012.
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-6390 Filed 3-15-12; 8:45 am]
BILLING CODE 4160-01-P