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Notice

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 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:

Thinh Nguyen, Center for Devices and Radiological Health (HFZ-402), Food and Drug Administration, 9200 Start Printed Page 15886Corporate Blvd., Rockville, MD 20850, 301-594-2186, ext. 152.

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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 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 Web site 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 § 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, 2006, through December 31, 2006. 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, 2006, through December 31, 2006.

PMA No./Docket No.ApplicantTrade NameApproval Date
P040027/2006M-0411W.L. Gore & AssociatesGORE VIATORR TIPSDecember 6, 2004
P040023/2006M-0512DePuy Orthopedics, Inc.DURALOC OPTION CERAMIC HIP SYSTEMMay 3, 2005
P030047/2006M-0412Cordis Corp.CORDIS PRECISE NITINOL STENTSeptember 22, 2006
P050038/2006M-0396Medafor, Inc.ARISTA AH ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASEDSeptember 26, 2006
P970053(S9)/2006M-0460Nidek, Inc.NIDEK EC-5000 EXCIMER LASEROctober 11, 2006
P050022/2006M-0456Siemens Medical Solutions USA, Inc.SYNGO LUNG COMPUTER ASSISTED DETECTION (CAD) SYSTEMOctober 18, 2006
P050025/2006M-0459Endotex Interventional Systems, Inc.ENDOTEX NEXSTENT CAROTID STENT & DELIVERY SYSTERM; AND ENDOTEX NEXSTENT CAROTID STENT & MONORAIL DELIVERY SYSTERMOctober 27, 2006
P020012/2006M-0455Artes Medical USA, Inc.ARTEFILLOctober 27, 2006
P040050/2006M-0457Uroplasty, Inc.MACROPLASTIQUE IMPLANTSOctober 30, 2006
P050031/2006M-0473Paragon Vision SciencesPARAGON Z CRTNovember 16, 2006
P020056/2006M-0490AllerganINAMED SILICONE-FILLED BREAST IMPLANTSNovember 17, 2006
P030053/2006M-0492Mentor Corp.MENTOR MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTSNovember 17, 2006
P060010/2006M-0529AbbeyMoor Medical, Inc.THE SPANNER TEMPORARY PROSTATIC STENTDecember 14, 2006
P040025/2006M-0530Olympic MedicalOLYMPIC COOL-CAPDecember 20, 2006
P050033/2006M-0531Anika Therapeutics, Inc.COSMETIC TISSUE AUGMENTATION PRODUCTDecember 20, 2006

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: March 22, 2007.

Linda S. Kahan,

Deputy Director, Center for Devices and Radiological Health.

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[FR Doc. E7-6166 Filed 4-2-07; 8:45 am]

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