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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 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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Thinh Nguyen, Center for Devices and Radiological Health (HFZ-402), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-2186 ext. 152.

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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 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 October 1, 2005 through December 31, 2005. 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 October 1, 2005 through December 31, 2005

PMA No./Docket No.ApplicantTrade NameApproval Date
P960040(S28)/2005M-0435Guidant CRM Corp.VENTAK PRIZM AVT AICD SYSTEMMarch 27, 2003
P020045/2005M-0475CryoCath Technologies, Inc.7F FREEZOR CARDIAC CRYOBLATION CATHETER & CCT.2 CRYOCONSOLE SYSTEMApril 17, 2003
P040003/2005M-0473InSightec—North AmericaEXABLATE 2000 SYSTEMOctober 22, 2004
P980022(S11)/2005M-0454Medtronic MiniMedGUARDIAN RT CONTINUOUS GLUCOSE MONITORING SYSTEMJuly 18, 2005
P020016/2005M-0399Walter Lorenz Surgical, Inc.TOTAL TEMPOMANDIBULAR JOINT REPLACEMENT SYSTEMSeptember 21, 2005
P040047/2005M-0477Bioform Medical, Inc.COAPTITENovember 10, 2005
P040042/2005M-0476Irvine Biomedical, Inc.THERAPY DUAL 8 CARDIAC ABLATION SYSTEMNovember 18, 2005
P030054(S10)/2005M-0492St. Jude Medical CRMDEPIC & ATLAS + HF CRT-D SYSTEMSNovember 18, 2005
P040013/2005M-0474Biomimetic Therapeutics, Inc.GEM 21S (GROWTH-FACTOR ENHANCED MATRIX)November 18, 2005
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P040045/2005M-0504Vistakon, Division of Johnson & Johnson Vision Care, Inc.VISTAKON (SENOFILCON A) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKERDecember 20, 2005

II. Electronic Access

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

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Dated: March 7, 2006.

Linda S. Kahan,

Deputy Director, Center for Devices and Radiological Health.

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[FR Doc. E6-3850 Filed 3-16-06; 8:45 am]