PMA P050018S008
- Device
- ANGIOSCULPT SCORING BALLOON CATHETER
- Applicant
- Spectranetics Corp.
- PMA number
- P050018
- Supplement
- S008
- Product code
- NWX
- Decision date
- 2009-10-08
- Classification
- Catheter, Percutaneous Transluminal Coronary Angioplasty (ptca), Cutting/scoring
- Generic name
- Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
- Approval order statement
- APPROVAL FOR MATERIAL CHANGES TO THE EASY-EXCHANGE (EX) DELIVERY SYSTEM.
Current openFDA PMA Record#
- Device
- ANGIOSCULPT SCORING BALLOON CATHETER
- Applicant
- Spectranetics Corp.
- PMA number
- P050018
- Supplement
- S008
- Product code
- NWX
- Generic name
- Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
- Decision date
- 2009-10-08
- Decision code
- APPR
- Date received
- 2009-08-10
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MATERIAL CHANGES TO THE EASY-EXCHANGE (EX) DELIVERY SYSTEM.