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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 Tigris Vascular Stent
Generic NameSTENT, SUPERFICIAL FEMORAL ARTERY
ApplicantW. L. Gore & Associates, Inc.
3250 W. Kiltie Ln.
Flagstaff, AZ 86005
PMA NumberP160004
Supplement NumberS008
Date Received02/07/2018
Decision Date04/13/2018
Withdrawal Date02/07/2020
Product Code NIP 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for updated labeling with post-approval study results.
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