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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameGORE VIABAHN ENDOPROSTHESIS
Classification Namestent, superficial femoral artery
ApplicantW.L. GORE & ASSOCIATES,INC
PMA NumberP040037
Supplement NumberS007
Date Received11/20/2007
Decision Date08/14/2008
Product Code
NIP[ Registered Establishments with NIP ]
Docket Number 08M-0467
Notice Date 08/21/2008
Advisory Committee Cardiovascular
Supplement Typepanel track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval of an extension of the indications for use to include iliac arterial lesions. The device is indicated for improving blood flow in patients with symptomatic peripheral arterial disease in iliac artery lesions with reference vessel diameters ranging from 4. 0-12. 0 mm.
Approval Order Approval Order
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