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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 WITH HEPARIN BIOACTIVE S4URFACE
Classification Namestent, superficial femoral artery
Generic Namestent, superficial femoral artery
Applicant
W.L. GORE & ASSOCIATES,INC
3450 west kiltie ln.
p.o. box 500
flagstaff, AZ 86002-0500
PMA NumberP040037
Supplement NumberS004
Date Received03/05/2007
Decision Date07/31/2007
Product Code
NIP[ Registered Establishments with NIP ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL OR THE ADDITION OF A HEPARIN COATING ON THE GORE VIABAHN ENDOPROSTHESIS, REFERRED TO AS THE HEPARIN BIOACTIVE SURFACE.
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