PMA P140026S006
- Device
- Enroute Transcarotid Stent System
- Applicant
- Boston Scientific Corporation
- PMA number
- P140026
- Supplement
- S006
- Product code
- NIM
- Decision date
- 2017-04-13
- Classification
- Stent, Carotid
- Generic name
- Stent, carotid
- Approval order statement
- Approval for changes to the protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- Enroute Transcarotid Stent System
- Applicant
- Boston Scientific Corporation
- PMA number
- P140026
- Supplement
- S006
- Product code
- NIM
- Generic name
- Stent, carotid
- Decision date
- 2017-04-13
- Decision code
- APPR
- Date received
- 2017-02-14
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- Approval for changes to the protocol for the post-approval study (PAS) protocol.