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 | S018 |
Date Received | 04/05/2021 |
Decision Date | 05/05/2021 |
Product Code |
NIM |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Implementing recertification procedures for returned stents. |
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