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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.

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Food and Drug Administration, HHS.




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.

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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.

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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

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 Start Printed Page 47211order 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.ApplicantTrade nameApproval date
P050050 FDA-2011-M-0323Small Bone Innovations, IncScandinavian total ankle replacement systemMay 27, 2009.
P060004(S1) FDA-2011-M-0256Carl Zeiss Meditec, IncMeditec MEL 80 excimer laser systemMarch 28, 2011.
P100040 FDA-2011-M-0257Medtronic VascularValiant thoracic stent graft systemApril 1, 2011.
H100002 FDA-2011-M-0241NeuroVasx, InccPAX aneurysm treatment systemApril 1, 2011.
P100018 FDA-2011-M-0284Chestnut Medical Technologies, IncPipeline embolization deviceApril 6, 2011.
P100034 FDA-2011-M-0295NovoCure, LtdNovoCure Ltd.'s NovoTTF-100A treatment kitApril 8, 2011.
P100020 FDA-2011-M-0300Roche Molecular Systems, Inccobas HPV testApril 19, 2011.
P100029 FDA-2011-M-0296St. Jude Medical, IncTrifecta heart valveApril 20, 2011.
P100023 FDA-2011-M-0342Boston Scientific CorpION paclitaxel-eluting coronary stent system (monorail and over-the-wire systems)April 22, 2011.
P930014 (S45) FDA-2011-M-0338Alcon Research, LtdAcrySof toric IOL and AcrySof IQ toric IOLMay 3, 2011.
P040012 (S34) FDA-2011-M-0343Abbott Vascular, IncRX Acculink carotid stent systemMay 6, 2011.
P090028 FDA-2011-M-0348Ortho-Clinical Diagnostics, IncVitros immunodiagnostic products HBeAg reagent pack/products HBeAg calibrator/products HBe controlsMay 11, 2011.
P100017 FDA-2011-M-0349Abbott Molecular, IncAbbott 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-glycosylaseMay 17, 2011.
P100013 FDA-2011-M-0430Cordis CorpCordis ExoSeal vascular closure deviceMay 19, 2011.
P070015 (S54) FDA-2011-M-0431Abbott VascularXience nano everolimus-eluting coronary stent system and Promus everolimus-eluting coronary stent systemMay 24, 2011.
P100014 FDA-2011-M-0445Oceana Therapeutics, IncSolesta injectable gelMay 27, 2011.
P090002 FDA-2011-M-0470Depuy Orthopaedics, IncPinnacle complete acetabular hip systemJune 13, 2011.
P100027 FDA-2011-M-0472Ventana Medical Systems, IncINFORM HER2 dual ISH DNA probe cocktailJune 14, 2011.
P100031 FDA-2011-M-0502Roche Diagnostics CorpElecsys anti-HBc immunoassay and Elecsys PreciControl anti-HBc for use on the modular Analytics E170 immunoassay analyzerJune 22, 2011.
P100032 FDA-2011-M-0503Roche Diagnostics CorpElecsys anti-HBc immunoassay and Elecsys PreciControl anti-HBc for use on the Elecsys 2010 immunoassay analyzerJune 27, 2011.

II. Electronic Access

Persons with access to the Internet may obtain the documents at​cdrh/​pmapage.html.

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Dated: July 29, 2011.

Nancy K. Stade,

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

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[FR Doc. 2011-19734 Filed 8-3-11; 8:45 am]