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 | S002 |
Date Received | 03/07/2016 |
Decision Date | 07/19/2016 |
Product Code |
NIM |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol - OSB |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of the following changes to the post-approval study for the device: editorial, protocol, exclusion changes, as well as verbage changes. |
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