PMA P050018S001
- Device
- ANGIOSCUPLT SCORING BALLOON CATHETER
- Applicant
- Spectranetics Corp.
- PMA number
- P050018
- Supplement
- S001
- Product code
- NWX
- Decision date
- 2007-03-07
- Classification
- Catheter, Percutaneous Transluminal Coronary Angioplasty (ptca), Cutting/scoring
- Generic name
- Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
- Approval order statement
- APPROVAL FOR MINOR CHANGES TO THE STRAIN RELIEF AND CATHETER SHAFT.
Current openFDA PMA Record#
- Device
- ANGIOSCUPLT SCORING BALLOON CATHETER
- Applicant
- Spectranetics Corp.
- PMA number
- P050018
- Supplement
- S001
- Product code
- NWX
- Generic name
- Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
- Decision date
- 2007-03-07
- Decision code
- APPR
- Date received
- 2007-02-07
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MINOR CHANGES TO THE STRAIN RELIEF AND CATHETER SHAFT.