- Device
- WLOVERINE Coronary Cutting Balloon
- Applicant
- Boston Scientific Corp
- PMA number
- P950020
- Supplement
- S128
- Product code
- NWX
- Generic name
- Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
- Decision date
- 2022-11-15
- Decision code
- OK30
- Date received
- 2022-10-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to a sterilization Chamber at the Boston Scientific Corporation (BSC) Coventry Rhode Island facility.