PMA P140028S020
- Device
- Innova Vascular Self-Expanding Stent With Delivery System
- Applicant
- Boston Scientific Corporation
- PMA number
- P140028
- Supplement
- S020
- Product code
- NIP
- Decision date
- 2016-12-01
- Classification
- Stent, Superficial Femoral Artery
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Approval order statement
- Modifications to the stent processing parameters.
Current openFDA PMA Record#
- Device
- Innova Vascular Self-Expanding Stent With Delivery System
- Applicant
- Boston Scientific Corporation
- PMA number
- P140028
- Supplement
- S020
- Product code
- NIP
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Decision date
- 2016-12-01
- Decision code
- OK30
- Date received
- 2016-11-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modifications to the stent processing parameters.