- Device
- PAS CHAMPION(TM) CATHETER 30 MM LONG BALLOONS
- Applicant
- Progressive Angioplasty Systems, Inc.
- PMA number
- P930012
- Supplement
- S004
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 1996-11-18
- Decision code
- APPR
- Date received
- 1996-06-27
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- ADDITION OF THE FOLLOWING BALLOON SIZES TO BE ADDED TO THE PAS CHAMPION(TM) PTCA CATHETER LINE: 2.5MM X 30MM; 3.0MM X 30MM; AND 3.5MM X 30MM