- Device
- WOLVERINE Coronary Cutting Balloon
- Applicant
- Boston Scientific Corp
- PMA number
- P950020
- Supplement
- S106
- Product code
- NWX
- Generic name
- Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
- Decision date
- 2020-05-19
- Decision code
- APPR
- Date received
- 2020-03-12
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a manufacturing site located at Boston Scientific Corp. in Ballybrit Business Park Galway, Ireland for sterilization.