PMA P140026S017
- Device
- ENROUTE TRANSCAROTID STENT SYSTEM
- Applicant
- Boston Scientific Corporation
- PMA number
- P140026
- Supplement
- S017
- Product code
- NIM
- Decision date
- 2021-03-30
- Generic name
- Stent, carotid
- Approval order statement
- Approval for changes to the tip pull test.
Current openFDA PMA Record#
- Device
- ENROUTE TRANSCAROTID STENT SYSTEM
- Applicant
- Boston Scientific Corporation
- PMA number
- P140026
- Supplement
- S017
- Product code
- NIM
- Generic name
- Stent, carotid
- Decision date
- 2021-03-30
- Decision code
- APPR
- Date received
- 2021-03-05
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for changes to the tip pull test.