- Device
- WOLVERINE™ Coronary Cutting Balloon®
- Applicant
- Boston Scientific Corp
- PMA number
- P950020
- Supplement
- S135
- Product code
- NWX
- Generic name
- Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
- Decision date
- 2023-03-10
- Decision code
- OK30
- Date received
- 2023-02-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change the in-process monitoring online sampling plan for extruded components at the Galway manufacturing site.