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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 (WITH HEPARIN BIOACTIVE SURFACE)
Classification Namestent, superficial femoral artery
ApplicantW.L. GORE & ASSOCIATES,INC
PMA NumberP040037
Supplement NumberS032
Date Received10/28/2010
Decision Date11/24/2010
Product Code
NIP[ Registered Establishments with NIP ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Modify a pressure vessel used in the heparin coating process.
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