PMA P950020S115
- Device
- WOLVERINE™ Coronary Cutting Balloon®
- Applicant
- Boston Scientific Corp
- PMA number
- P950020
- Supplement
- S115
- Product code
- NWX
- Decision date
- 2021-12-06
- Generic name
- Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
- Approval order statement
- Addition of a new cleanroom in building 2 (under the same FDA establishment inspection number).
Current openFDA PMA Record#
- Device
- WOLVERINE™ Coronary Cutting Balloon®
- Applicant
- Boston Scientific Corp
- PMA number
- P950020
- Supplement
- S115
- Product code
- NWX
- Generic name
- Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
- Decision date
- 2021-12-06
- Decision code
- OK30
- Date received
- 2021-11-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a new cleanroom in building 2 (under the same FDA establishment inspection number).