PMA P950020S081
- Device
- Flextome Cutting Balloon Microsurgical Dilatation Device/Wolverine Coronary Cutting Balloon Monorail (MR) / Wolverine Co
- Applicant
- Boston Scientific Corp
- PMA number
- P950020
- Supplement
- S081
- Product code
- NWX
- Decision date
- 2017-08-18
- Classification
- Catheter, Percutaneous Transluminal Coronary Angioplasty (ptca), Cutting/scoring
- Generic name
- Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
- Approval order statement
- Alternate degreaser used in the cleaning process for the cutting blades (atherotomes).
Current openFDA PMA Record#
- Device
- Flextome Cutting Balloon Microsurgical Dilatation Device/Wolverine Coronary Cutting Balloon Monorail (MR) / Wolverine Co
- Applicant
- Boston Scientific Corp
- PMA number
- P950020
- Supplement
- S081
- Product code
- NWX
- Generic name
- Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
- Decision date
- 2017-08-18
- Decision code
- OK30
- Date received
- 2017-07-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternate degreaser used in the cleaning process for the cutting blades (atherotomes).