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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 NumberS021
Date Received09/18/2018
Decision Date10/11/2018
Withdrawal Date02/07/2020
Product Code NIP 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Implementation of an additional resin blend pelletizer that is used in the manufacturing process of base tube device components.
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