PMA P140026S002
- Device
- ENROUTE TRANSCAROTID STENT SYSTEM
- Applicant
- Boston Scientific Corporation
- PMA number
- P140026
- Supplement
- S002
- Product code
- NIM
- Decision date
- 2016-07-19
- Classification
- Stent, Carotid
- Generic name
- Stent, carotid
- Approval order statement
- Approval of the following changes to the post-approval study for the device: editorial, protocol, exclusion changes, as well as verbage changes.
Current openFDA PMA Record#
- Device
- ENROUTE TRANSCAROTID STENT SYSTEM
- Applicant
- Boston Scientific Corporation
- PMA number
- P140026
- Supplement
- S002
- Product code
- NIM
- Generic name
- Stent, carotid
- Decision date
- 2016-07-19
- Decision code
- APPR
- Date received
- 2016-03-07
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- Approval of the following changes to the post-approval study for the device: editorial, protocol, exclusion changes, as well as verbage changes.