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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 Carotid Stent
Classification Namestent, carotid
Generic Namestent, carotid
W. L Gore & Associates, Inc
4250 w. kiltie lane
flagship, AZ 86005
PMA NumberP180010
Supplement NumberS003
Date Received02/04/2019
Decision Date03/06/2019
Product Code
NIM[ Registered Establishments with NIM ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Update raw material specifications and non-compendial test methods.