PMA P140026S005
- Device
- ENROUTE TRANSCAROTID STENT SYSTEM
- Applicant
- Boston Scientific Corporation
- PMA number
- P140026
- Supplement
- S005
- Product code
- NIM
- Decision date
- 2017-07-18
- Classification
- Stent, Carotid
- Generic name
- Stent, carotid
- Approval order statement
- Approval for labeling updates to incorporate the ROADSTER Study Continued Access data.
Current openFDA PMA Record#
- Device
- ENROUTE TRANSCAROTID STENT SYSTEM
- Applicant
- Boston Scientific Corporation
- PMA number
- P140026
- Supplement
- S005
- Product code
- NIM
- Generic name
- Stent, carotid
- Decision date
- 2017-07-18
- Decision code
- APPR
- Date received
- 2017-01-31
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for labeling updates to incorporate the ROADSTER Study Continued Access data.