PMA P140026S013
- Device
- ENROUTE Transcarotid Stent System
- Applicant
- Boston Scientific Corporation
- PMA number
- P140026
- Supplement
- S013
- Product code
- NIM
- Decision date
- 2019-09-04
- Classification
- Stent, Carotid
- Generic name
- Stent, carotid
- Approval order statement
- Transfer of Final Release activities from the Cordis Miami Lakes site to the Cordis de Mexico site.
Current openFDA PMA Record#
- Device
- ENROUTE Transcarotid Stent System
- Applicant
- Boston Scientific Corporation
- PMA number
- P140026
- Supplement
- S013
- Product code
- NIM
- Generic name
- Stent, carotid
- Decision date
- 2019-09-04
- Decision code
- OK30
- Date received
- 2019-08-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Transfer of Final Release activities from the Cordis Miami Lakes site to the Cordis de Mexico site.