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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 NumberS007
Date Received11/20/2007
Decision Date08/14/2008
Product Code NIP 
Docket Number 08M-0467
Notice Date 08/21/2008
Advisory Committee Cardiovascular
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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