- Device
- ENROUTE Transcarotid Stent System
- Applicant
- Boston Scientific Corporation
- PMA number
- P140026
- Supplement
- S020
- Product code
- NIM
- Generic name
- Stent, carotid
- Decision date
- 2022-07-20
- Decision code
- APPR
- Date received
- 2022-05-12
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for receiving, inspection, and distribution of finished goods at a manufacturing site located at 14755 27th Ave N, Plymouth, MN 55447.