PMA P950020S134
- Device
- WOLVERINE™ Coronary Cutting Balloon®
- Applicant
- Boston Scientific Corp
- PMA number
- P950020
- Supplement
- S134
- Product code
- NWX
- Decision date
- 2023-01-18
- Generic name
- Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
- Approval order statement
- Relocate manufacturing equipment from one cleanroom to another at the same manufacturing facility.
Current openFDA PMA Record#
- Device
- WOLVERINE™ Coronary Cutting Balloon®
- Applicant
- Boston Scientific Corp
- PMA number
- P950020
- Supplement
- S134
- Product code
- NWX
- Generic name
- Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
- Decision date
- 2023-01-18
- Decision code
- OK30
- Date received
- 2023-01-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Relocate manufacturing equipment from one cleanroom to another at the same manufacturing facility.