PMA P140026S025
- Device
- ENROUTE® Transcarotid Stent System
- Applicant
- Boston Scientific Corporation
- PMA number
- P140026
- Supplement
- S025
- Product code
- NIM
- Decision date
- 2022-12-16
- Generic name
- Stent, carotid
- Approval order statement
- In-source polytetrafluorethylene (PTFE) component manufacturing.
Current openFDA PMA Record#
- Device
- ENROUTE® Transcarotid Stent System
- Applicant
- Boston Scientific Corporation
- PMA number
- P140026
- Supplement
- S025
- Product code
- NIM
- Generic name
- Stent, carotid
- Decision date
- 2022-12-16
- Decision code
- OK30
- Date received
- 2022-11-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- In-source polytetrafluorethylene (PTFE) component manufacturing.