PMA P050018S018
- Device
- ANGIOSCULPT PTCA SCORING BALLOON CATHETER - RAPID EXCHANGE (RX), ANGIOSCULPT PTCS SCORING BALLOON CATHETER - EASY EXCHAN
- Applicant
- Spectranetics Corp.
- PMA number
- P050018
- Supplement
- S018
- Product code
- NWX
- Decision date
- 2013-05-20
- Classification
- Catheter, Percutaneous Transluminal Coronary Angioplasty (ptca), Cutting/scoring
- Generic name
- Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
- Approval order statement
- APPROVAL FOR REVISIONS TO THE INSTRUCTIONS FOR USE LABELING.
Current openFDA PMA Record#
- Device
- ANGIOSCULPT PTCA SCORING BALLOON CATHETER - RAPID EXCHANGE (RX), ANGIOSCULPT PTCS SCORING BALLOON CATHETER - EASY EXCHAN
- Applicant
- Spectranetics Corp.
- PMA number
- P050018
- Supplement
- S018
- Product code
- NWX
- Generic name
- Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
- Decision date
- 2013-05-20
- Decision code
- APPR
- Date received
- 2012-11-30
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR REVISIONS TO THE INSTRUCTIONS FOR USE LABELING.