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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 & GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
Classification Namestent, superficial femoral artery
ApplicantW.L. GORE & ASSOCIATES,INC
PMA NumberP040037
Supplement NumberS033
Date Received01/03/2011
Decision Date04/20/2011
Product Code
NIP[ Registered Establishments with NIP ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for changes to the sterilization process.
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