PMA P050018S017
- Device
- ANGIOSCULPT PTCA SCORING BALLOON CATHETER
- Applicant
- Spectranetics Corp.
- PMA number
- P050018
- Supplement
- S017
- Product code
- NWX
- Decision date
- 2013-01-10
- Classification
- Catheter, Percutaneous Transluminal Coronary Angioplasty (ptca), Cutting/scoring
- Generic name
- Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
- Approval order statement
- APPROVAL FOR A NEW BALLOON LENGTH, AND TO INCORPORATE DESIGN, MANUFACTURING PROCESS AND LABELING CHANGES FOR THE RAPID EXCHANGE (RX) DELIVERY SYSTEM.
Current openFDA PMA Record#
- Device
- ANGIOSCULPT PTCA SCORING BALLOON CATHETER
- Applicant
- Spectranetics Corp.
- PMA number
- P050018
- Supplement
- S017
- Product code
- NWX
- Generic name
- Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
- Decision date
- 2013-01-10
- Decision code
- APPR
- Date received
- 2012-05-10
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A NEW BALLOON LENGTH, AND TO INCORPORATE DESIGN, MANUFACTURING PROCESS AND LABELING CHANGES FOR THE RAPID EXCHANGE (RX) DELIVERY SYSTEM.