PMA P140026S008
- Device
- ENROUTE Transcarotid Stent System
- Applicant
- Boston Scientific Corporation
- PMA number
- P140026
- Supplement
- S008
- Product code
- NIM
- Decision date
- 2018-02-14
- Classification
- Stent, Carotid
- Generic name
- Stent, carotid
- Approval order statement
- Tighten a specification and add an in-process test.
Current openFDA PMA Record#
- Device
- ENROUTE Transcarotid Stent System
- Applicant
- Boston Scientific Corporation
- PMA number
- P140026
- Supplement
- S008
- Product code
- NIM
- Generic name
- Stent, carotid
- Decision date
- 2018-02-14
- Decision code
- OK30
- Date received
- 2018-01-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Tighten a specification and add an in-process test.