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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 (HFZ-402), 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 FDA believes that this procedure expedites public notification of these actions because announcements can be placed on the Internet more quickly than they can be published in the Federal Register, and FDA believes that the Internet is accessible to more people than the Federal Register.

In accordance with section 515(d)(4) and (e)(2) of the Federal Food, Drug, and Cosmetic Act (the 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 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 Start Printed Page 51289Internet. 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, 2009, through March 31, 2009. 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, 2009, through March 31, 2009

PMA No. Docket No.ApplicantTrade NameApproval Date
P060030 FDA-2009-M-0033Roche Molecular Systems, Inc.Cobas ampliprep/cobas taqman HFC testOctober 30, 2008
P950009 (S8) FDA-2009-M-0016BD DiagnosticsBD focal point gs imaging systemDecember 3, 2008
P080010 FDA-2009-M-0034Advanced Medical Optics, Inc.Tecnis multifocal foldable posterior chamber intraocular lensJanuary 16, 2009
P080021 FDA-2009-M-0049Advanced Vision Science, Inc.xact foldable hydrophobic acrylic UV light absorbing posterior chamber IOLFebruary 2, 2009
P030031 (S11) FDA-2009-M-0071Biosense Webster, Inc.Navistar & Celsius thermo cool cathetersFebruary 6, 2009
P070014 FDA-2009-M-0127Bard Peripheral Vascular, Inc.lifestent flexstar & flexstar XL vascular stent systemFebruary 13, 2009
P940015 (S12) FDA-2009-M-0128Genzyme Corp.Synvisc-OneFebruary 26, 2009
P070005 FDA-2009-M-0135Synthemed Corp.Repel-cv bioresorbable adhesion barrierMarch 6, 2009
P080002 FDA-2009-M-0159The Female Health Co.FC2 female condomMarch 10, 2009

II. Electronic Access

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

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Dated: September 24, 2009.

Jeffrey Shuren,

Acting Director, Center for Devices and Radiological Health.

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[FR Doc. E9-23962 Filed 10-5-09; 8:45 am]