- Device
- WOLVERINE™ Coronary Cutting Balloon®
- Applicant
- Boston Scientific Corp
- PMA number
- P950020
- Supplement
- S140
- Product code
- NWX
- Generic name
- Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
- Decision date
- 2023-08-03
- Decision code
- OK30
- Date received
- 2023-07-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Adjust the settings of the pre-blade bonding plasma process and to remove the O2 plasma accessory tray cleaning cycle.