- Device
- Innova Vascular Self-Expanding Stent with Delivery System
- Applicant
- Boston Scientific Corporation
- PMA number
- P140028
- Supplement
- S057
- Product code
- NIP
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Decision date
- 2020-04-13
- Decision code
- OK30
- Date received
- 2020-03-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update to the sterilization cycle at the BSC Coventry, Rhode Island facility and the Steris Tullamore, Ireland contract sterilization facility.