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. |
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Device | ENROUTE Transcarotid Stent System |
Generic Name | STENT, CAROTID |
Applicant | SILK ROAD MEDICAL, INC 1213 Innsbruck Drive Sunnyvale, CA 94089 |
PMA Number | P140026 |
Supplement Number | S023 |
Date Received | 06/21/2022 |
Decision Date | 08/19/2022 |
Product Code |
NIM |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT05365490
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Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of the revised protocol for the ROADSTER 3 post-approval study (PAS) protocol. |
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