PMA P140028S088
- Device
- Innova™ Vascular Self-Expanding Stent with Delivery System
- Applicant
- Boston Scientific Corporation
- PMA number
- P140028
- Supplement
- S088
- Product code
- NIP
- Decision date
- 2026-08-21
- Classification
- Cardiovascular
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Approval order statement
- implementation of parametric release and an alternate biological indicator at the sterilization sites
Current openFDA PMA Record#
- Device
- Innova™ Vascular Self-Expanding Stent with Delivery System
- Applicant
- Boston Scientific Corporation
- PMA number
- P140028
- Supplement
- S088
- Product code
- NIP
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Decision date
- 2026-08-21
- Decision code
- OK30
- Date received
- 2026-07-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- implementation of parametric release and an alternate biological indicator at the sterilization sites