PMA P050018S007
- Device
- ANGIOSCULPT PTCA SCORING BALLOON CATHETER
- Applicant
- Spectranetics Corp.
- PMA number
- P050018
- Supplement
- S007
- Product code
- NWX
- Decision date
- 2009-06-19
- Classification
- Catheter, Percutaneous Transluminal Coronary Angioplasty (ptca), Cutting/scoring
- Generic name
- Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
- Approval order statement
- APPROVAL FOR THE ADDITION OF FURTHER USER INSTRUCTIONS IN THE INSTRUCTIONS FOR USE (IFU) TO ENHANCE THE SAFE USE OF THE MONORAIL (EASY EXCHANGE) DELIVERY PLATFORM OF THE ANGIOSCULPT SCORING BALLOON CATHETER.
Current openFDA PMA Record#
- Device
- ANGIOSCULPT PTCA SCORING BALLOON CATHETER
- Applicant
- Spectranetics Corp.
- PMA number
- P050018
- Supplement
- S007
- Product code
- NWX
- Generic name
- Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
- Decision date
- 2009-06-19
- Decision code
- APPR
- Date received
- 2009-05-20
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR THE ADDITION OF FURTHER USER INSTRUCTIONS IN THE INSTRUCTIONS FOR USE (IFU) TO ENHANCE THE SAFE USE OF THE MONORAIL (EASY EXCHANGE) DELIVERY PLATFORM OF THE ANGIOSCULPT SCORING BALLOON CATHETER.