PMA P930012S005

Device: PAS CHAMPION HP PTCA CATHETER
Applicant: Progressive Angioplasty Systems, Inc.
PMA number: P930012
Supplement: S005
Product code: LOX
Decision date: 1997-01-29
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Approval order 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.

Current openFDA PMA Record#

Device: PAS CHAMPION HP PTCA CATHETER
Applicant: Progressive Angioplasty Systems, Inc.
PMA number: P930012
Supplement: S005
Product code: LOX
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Decision date: 1997-01-29
Decision code: APPR
Date received: 1996-08-01
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order 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.