PMA P950020S086
- Device
- Wolverine Coronary Cutting Balloon (Monorail; Over-theWire)
- Applicant
- Boston Scientific Corp
- PMA number
- P950020
- Supplement
- S086
- Product code
- NWX
- Decision date
- 2017-11-15
- Classification
- Catheter, Percutaneous Transluminal Coronary Angioplasty (ptca), Cutting/scoring
- Generic name
- Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
- Approval order statement
- Modify the inflation pressure used during the cutting balloon leak test.
Current openFDA PMA Record#
- Device
- Wolverine Coronary Cutting Balloon (Monorail; Over-theWire)
- Applicant
- Boston Scientific Corp
- PMA number
- P950020
- Supplement
- S086
- Product code
- NWX
- Generic name
- Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
- Decision date
- 2017-11-15
- Decision code
- OK30
- Date received
- 2017-10-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modify the inflation pressure used during the cutting balloon leak test.