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

Federal Register: October 6, 2009 (Volume 74, Number 192)

Notices

Page 51288-51289

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

DOCID:fr06oc09-59

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Docket Nos. FDA-2009-M-0033, FDA-2009-M-0016, FDA-2009-M-0034, FDA- 2009-M-0049, FDA-2009-M-0071, FDA-2009-M-0127, FDA-2009-M-0128, FDA- 2009-M-0135, FDA-2009-M-0159

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 (HFZ-402), Food and Drug Administration, 10903

New Hampshire Ave., Bldg. 66, rm. 1650, Silver Spring, MD 20993, 301- 796-6570.

SUPPLEMENTARY INFORMATION:

1. 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. 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 Sec. 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

   Page 51289

   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, 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

   Approval

   PMA No. Docket No.

   Applicant

   Trade Name

   Date

   P060030

   Roche Molecular Cobas ampliprep/

   October 30,

   FDA-2009-M-0033

   Systems, Inc.

   cobas taqman HFC

   2008 test

   P950009 (S8)

   BD Diagnostics

   BD focal point gs

   December 3,

   FDA-2009-M-0016

   imaging system

   2008

   P080010

   Advanced Medical Tecnis multifocal

   January 16,

   FDA-2009-M-0034

   Optics, Inc.

   foldable posterior 2009 chamber intraocular lens

   P080021

   Advanced Vision xact foldable

   February 2,

   FDA-2009-M-0049

   Science, Inc.

   hydrophobic

   2009 acrylic UV light absorbing posterior chamber

   IOL

   P030031 (S11)

   Biosense

   Navistar & Celsius February 6,

   FDA-2009-M-0071

   Webster, Inc.

   thermo cool

   2009 catheters

   P070014

   Bard Peripheral lifestent flexstar February 13,

   FDA-2009-M-0127

   Vascular, Inc.

   & flexstar XL

   2009 vascular stent system

   P940015 (S12)

   Genzyme Corp.

   Synvisc-One

   February 26,

   FDA-2009-M-0128

   2009

   P070005

   Synthemed Corp. Repel-cv

   March 6,

   FDA-2009-M-0135

   bioresorbable

   2009 adhesion barrier

   P080002

   The Female

   FC2 female condom

   March 10,

   FDA-2009-M-0159

   Health Co.

   2009

2. Electronic Access

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

   Dated: September 24, 2009.

   Jeffrey Shuren,

   Acting Director, Center for Devices and Radiological Health.

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

   BILLING CODE 4160-01-S