PAS CHAMPION HP PTCA CATHETER
FDA premarket approval P930012/S005 · decided 1997-01-29
Approval details
- PMA number
- P930012
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PAS CHAMPION HP PTCA CATHETER
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Progressive Angioplasty Systems, Inc.
- Date received
- 1996-08-01
- Decision date
- 1997-01-29
- Days to decision
- 181 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Menlo Park, CA
- Statement
- APPROVAL FOR THE PAS CHAMPION(TM) HP (HIGH PRESSURE) PTCA CATHETER WITH THE FOLLOWING BALLOON SIZES:3.0 MM, 3.5 MM, 4.0 MM DIAMETERS WITH 15 MM AND 20 MM LENGTHS. THIS DEVICE IS INDICATED FOR BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION.
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