PMA P140026S014
- Device
- ENROUTE Transcarotid Stent System
- Applicant
- Boston Scientific Corporation
- PMA number
- P140026
- Supplement
- S014
- Product code
- NIM
- Decision date
- 2020-06-04
- Generic name
- Stent, carotid
- Approval order statement
- Approval for the addition of the ROADSTER 2 Post-Approval Study results to the Instructions for Use.
Current openFDA PMA Record#
- Device
- ENROUTE Transcarotid Stent System
- Applicant
- Boston Scientific Corporation
- PMA number
- P140026
- Supplement
- S014
- Product code
- NIM
- Generic name
- Stent, carotid
- Decision date
- 2020-06-04
- Decision code
- APPR
- Date received
- 2019-12-17
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the addition of the ROADSTER 2 Post-Approval Study results to the Instructions for Use.