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

Document Details

Information about this document as published in the Federal Register.

Published Document

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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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.

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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.

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SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of January 30, 1998 (63 FR 4571), FDA published a final rule that amended 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 January 1, 2011, through March 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 January 1, 2011, Through March 31, 2011

PMA No. Docket No.ApplicantTrade nameApproval date
P010012 (S230)Boston Scientific CorpBOSTON SCIENTIFIC CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORSSeptember 16, 2010.
FDA-2011-M-0034
P100021Medtronic VascularMEDTRONIC VASCULAR ENDURANT STENT GRAFT SYSTEMDecember 16, 2010.
FDA-2011-M-0040
P100010Medtronic Cryocath, LPARCTIC FRONT CRYOCATHETER SYSTEMDecember 17, 2010.
FDA-2011-M-0041
P070014 (S10)Bard Peripheral VascularLIFESTENT AND LIFESTENT LX VASCULAR STENT SYSTEMSDecember 23, 2010.
FDA-2011-M-0039
P070026Depuy, IncCERAMAX CERAMIC HIP SYSTEMDecember 23, 2010.
FDA-2011-M-0035
P100028Cook Medical, IncFORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEMJanuary 14, 2011.
FDA-2011-M-0056
P090013Medtronic, IncREVO MRI SURESCAN IPG AND PACING SYSTEMFebruary 8, 2011.
FDA-2011-M-0105
P080003Hologic, IncSELENIA DIMENSIONS 3D SYSTEMSFebruary 11, 2011.
FDA2011-M-0131
P080027 (S1)OraSure Technologies, IncORAQUICK HCV RAPID ANTIBODY TESTFebruary 18, 2011.
FDA-2011-M-0132
H080005Elana, IncELANA SURGICAL KIT HUDMarch 10, 2011.
FDA-2011-M-0170
P080025Medtronic NeuromodulationMEDTRONIC INTERSTIM THERAPY SYSTEMMarch 14, 2011.
FDA-2011-M-0175
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P80020Seikagaku CorpGEL-ONEMarch 22, 2011.
FDA-2011-M-0198

II. Electronic Access

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

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Dated: May 27, 2011.

Nancy K. Stade,

Deputy Director for Policy Center for Devices and Radiological Health.

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[FR Doc. 2011-13692 Filed 6-1-11; 8:45 am]

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