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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 AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
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 NumberS043
Date Received05/03/2012
Decision Date05/30/2012
Product Code
NIP[ Registered Establishments with NIP ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
ADDITION OF LEAK TESTING AND DRYING OF GRAFT COMPONENTS AT THE MEDICAL EAST MANUFACTURING FACILITY.
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