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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.
 
DeviceENROUTE TRANSCAROTID STENT SYSTEM
Generic NameSTENT, CAROTID
ApplicantSILK ROAD MEDICAL, INC
1213 Innsbruck Drive
Sunnyvale, CA 94089
PMA NumberP140026
Supplement NumberS017
Date Received03/05/2021
Decision Date03/30/2021
Product Code NIM 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for changes to the tip pull test.
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