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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 & GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
Generic NameSTENT, SUPERFICIAL FEMORAL ARTERY
ApplicantW. L. Gore & Associates, Inc.
3450 W. Kiltie Ln.
P.O. Box 500
Flagstaff, AZ 86002
PMA NumberP040037
Supplement NumberS033
Date Received01/03/2011
Decision Date04/20/2011
Product Code NIP 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR CHANGES TO THE STERILIZATION PROCESS.
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