PMA P140026S010
- Device
- Enroute Transcarotid Stent System
- Applicant
- Boston Scientific Corporation
- PMA number
- P140026
- Supplement
- S010
- Product code
- NIM
- Decision date
- 2018-08-16
- Classification
- Stent, Carotid
- Generic name
- Stent, carotid
- Approval order statement
- Approval for label printing and final packaging at a manufacturing site located at 1213 Innsbruck Drive, Sunnyvale, California.
Current openFDA PMA Record#
- Device
- Enroute Transcarotid Stent System
- Applicant
- Boston Scientific Corporation
- PMA number
- P140026
- Supplement
- S010
- Product code
- NIM
- Generic name
- Stent, carotid
- Decision date
- 2018-08-16
- Decision code
- APPR
- Date received
- 2018-04-23
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for label printing and final packaging at a manufacturing site located at 1213 Innsbruck Drive, Sunnyvale, California.