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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 & ENDOPROSTHESIS WITH HERPARIN BIOACTIVE SURFACE
Classification Namestent, superficial femoral artery
ApplicantW.L. GORE & ASSOCIATES,INC
PMA NumberP040037
Supplement NumberS041
Date Received01/11/2012
Decision Date02/06/2012
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 No
Approval Order Statement 
Temperature change in the device loading process.
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