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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
Generic Namestent, carotid
Applicant
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 
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.
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