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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 NumberS013
Date Received08/05/2019
Decision Date09/04/2019
Product Code NIM 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Transfer of Final Release activities from the Cordis Miami Lakes site to the Cordis de Mexico site.
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