PMA P140026S016
- Device
- ENROUTE Transcarotid Stent System
- Applicant
- Boston Scientific Corporation
- Product code
- NIM
- Decision date
- 2022-04-28
- Generic name
- Stent, carotid
- 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.
Current openFDA PMA Record#
- Device
- ENROUTE Transcarotid Stent System
- Applicant
- Boston Scientific Corporation
- PMA number
- P140026
- Supplement
- S016
- Product code
- NIM
- Generic name
- Stent, carotid
- Decision date
- 2022-04-28
- Decision code
- APPR
- Date received
- 2021-02-23
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- 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.