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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceGORE VIABAHN ENDOPROSTHESIS
Generic NameSTENT, SUPERFICIAL FEMORAL ARTERY
ApplicantW.L. GORE & ASSOCIATES,INC
3450 WEST KILTIE LN.
P.O. BOX 500
FLAGSTAFF, AZ 86002-0500
PMA NumberP040037
Supplement NumberS002
Date Received08/11/2006
Decision Date02/08/2007
Product Code NIP 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR MODIFICATIONS TO THE ENDOPROSTHESIS AND DELIVERY CATHETER DESIGN TO REDUCE THE OVERALL DELIVERY PROFILE OF THE DEVICE BY ONE FRENCH SIZE.
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