PAS CHAMPION(TM) CATHETER 30 MM LONG BALLOONS
FDA premarket approval P930012/S004 · decided 1996-11-18
Approval details
- PMA number
- P930012
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PAS CHAMPION(TM) CATHETER 30 MM LONG BALLOONS
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Progressive Angioplasty Systems, Inc.
- Date received
- 1996-06-27
- Decision date
- 1996-11-18
- Days to decision
- 144 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Menlo Park, CA
- 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
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