|
Device | ENROUTE Transcarotid Stent System |
Generic Name | STENT, CAROTID |
Applicant | Boston Scientific Corporation 300 Boston Scientific Way Marlborough, MA 01752 |
PMA Number | P140026 |
Supplement Number | S016 |
Date Received | 02/23/2021 |
Decision Date | 04/28/2022 |
Product Code |
NIM |
Docket Number | 22M-0746 |
Notice Date | 05/06/2022 |
Advisory Committee |
Cardiovascular |
Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Predetermined Change Control Plan Authorized | No |
Approval Order Statement Approval for the expansion of the Indications for Use to include treatment of patients at standard risk for adverse events from carotid endartectomy. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|
Post-Approval Study | Show Report Schedule and Study Progress |