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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 NumberS023
Date Received06/21/2022
Decision Date08/19/2022
Product Code NIM 
Advisory Committee Cardiovascular
Clinical TrialsNCT05365490
Supplement Typenormal 180 day track no user fee
Supplement Reason postapproval study protocol
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval of the revised protocol for the ROADSTER 3 post-approval study (PAS) protocol.
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