- Device
- Wolverine™ Coronary Cutting Balloon (Monorail)
- Applicant
- Boston Scientific Corp
- PMA number
- P950020
- Supplement
- S144
- Product code
- NWX
- Generic name
- Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
- Decision date
- 2024-12-10
- Decision code
- OK30
- Date received
- 2024-10-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a re-ordered sterilization process to reduce the number EO sterilization cycles being required