PMA P140026S012
- Device
- ENROUTE TRANSCAROTID STENT SYSTEM
- Applicant
- Boston Scientific Corporation
- PMA number
- P140026
- Supplement
- S012
- Product code
- NIM
- Decision date
- 2019-04-30
- Classification
- Stent, Carotid
- Generic name
- Stent, carotid
- Approval order statement
- a process improvement to upgrade the sterilization vessel control system and associated mechanical components
Current openFDA PMA Record#
- Device
- ENROUTE TRANSCAROTID STENT SYSTEM
- Applicant
- Boston Scientific Corporation
- PMA number
- P140026
- Supplement
- S012
- Product code
- NIM
- Generic name
- Stent, carotid
- Decision date
- 2019-04-30
- Decision code
- OK30
- Date received
- 2019-04-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a process improvement to upgrade the sterilization vessel control system and associated mechanical components