- Device
- ENROUTE Transcarotid Stent System
- Applicant
- Boston Scientific Corporation
- PMA number
- P140026
- Supplement
- S015
- Product code
- NIM
- Generic name
- Stent, carotid
- Decision date
- 2020-06-01
- Decision code
- OK30
- Date received
- 2020-05-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Updates to the software and mechanical components of the control system for Vessel 2 and Vessel 4 at the Steris, El Paso, TX ethylene oxide sterilization facility.