2011-19734. 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 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, 301-796-6570.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of January 30, 1998 (63 FR 4571), FDA published a final rule that revised 21 CFR 814.44(d) and 814.45(d) to discontinue individual publication of PMA approvals and denials in the Federal Register. Instead, the Agency now posts this information on the Internet on FDA's home page at http://www.fda.gov.

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 April 1, 2011, through June 30, 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 April 1, 2011, Through June 30, 2011

PMA No./Docket No.	Applicant	Trade name	Approval date
P050050 FDA-2011-M-0323	Small Bone Innovations, Inc	Scandinavian total ankle replacement system	May 27, 2009.
P060004(S1) FDA-2011-M-0256	Carl Zeiss Meditec, Inc	Meditec MEL 80 excimer laser system	March 28, 2011.
P100040 FDA-2011-M-0257	Medtronic Vascular	Valiant thoracic stent graft system	April 1, 2011.
H100002 FDA-2011-M-0241	NeuroVasx, Inc	cPAX aneurysm treatment system	April 1, 2011.
P100018 FDA-2011-M-0284	Chestnut Medical Technologies, Inc	Pipeline embolization device	April 6, 2011.
P100034 FDA-2011-M-0295	NovoCure, Ltd	NovoCure Ltd.'s NovoTTF-100A treatment kit	April 8, 2011.
P100020 FDA-2011-M-0300	Roche Molecular Systems, Inc	cobas HPV test	April 19, 2011.
P100029 FDA-2011-M-0296	St. Jude Medical, Inc	Trifecta heart valve	April 20, 2011.
P100023 FDA-2011-M-0342	Boston Scientific Corp	ION paclitaxel-eluting coronary stent system (monorail and over-the-wire systems)	April 22, 2011.
P930014 (S45) FDA-2011-M-0338	Alcon Research, Ltd	AcrySof toric IOL and AcrySof IQ toric IOL	May 3, 2011.
P040012 (S34) FDA-2011-M-0343	Abbott Vascular, Inc	RX Acculink carotid stent system	May 6, 2011.
P090028 FDA-2011-M-0348	Ortho-Clinical Diagnostics, Inc	Vitros immunodiagnostic products HBeAg reagent pack/products HBeAg calibrator/products HBe controls	May 11, 2011.
P100017 FDA-2011-M-0349	Abbott Molecular, Inc	Abbott RealTi m e HCV, Abbott RealTi m e HCV amplification reagent kit, Abbott RealTi m e HCV control kit, Abbott RealTi m e HCV calibrator kit, and optional UNG Uracil-N-glycosylase	May 17, 2011.
P100013 FDA-2011-M-0430	Cordis Corp	Cordis ExoSeal vascular closure device	May 19, 2011.
P070015 (S54) FDA-2011-M-0431	Abbott Vascular	Xience nano everolimus-eluting coronary stent system and Promus everolimus-eluting coronary stent system	May 24, 2011.
P100014 FDA-2011-M-0445	Oceana Therapeutics, Inc	Solesta injectable gel	May 27, 2011.
P090002 FDA-2011-M-0470	Depuy Orthopaedics, Inc	Pinnacle complete acetabular hip system	June 13, 2011.
P100027 FDA-2011-M-0472	Ventana Medical Systems, Inc	INFORM HER2 dual ISH DNA probe cocktail	June 14, 2011.
P100031 FDA-2011-M-0502	Roche Diagnostics Corp	Elecsys anti-HBc immunoassay and Elecsys PreciControl anti-HBc for use on the modular Analytics E170 immunoassay analyzer	June 22, 2011.
P100032 FDA-2011-M-0503	Roche Diagnostics Corp	Elecsys anti-HBc immunoassay and Elecsys PreciControl anti-HBc for use on the Elecsys 2010 immunoassay analyzer	June 27, 2011.

II. Electronic Access

Persons with access to the Internet may obtain the documents at http://www.fda.gov/​cdrh/​pmapage.html.

Dated: July 29, 2011.

Nancy K. Stade,

Deputy Director for Policy, Center for Devices and Radiological Health.