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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 NumberS014
Date Received12/17/2019
Decision Date06/04/2020
Product Code NIM 
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the addition of the ROADSTER 2 Post-Approval Study results to the Instructions for Use.
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