PMA P880003S062

Device: VALOR AND VALOR XL PTCA DILATATION CATHETERS
Applicant: Cordis Corp.
PMA number: P880003
Supplement: S062
Product code: LOX
Decision date: 1996-11-07
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Approval order statement: APPROVAL FOR QUARTER-SIZE BALLOONS ON THE VALOR AND VALOR XL PTCA DILATATION CATHETERS WHICH ARE INDICATED FOR BALLOON DILATATION OF THE STENOTIC PORTION O F A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPSOE OF IMPROVING MYOCARDIAL PERFUSION

Current openFDA PMA Record

Device: VALOR AND VALOR XL PTCA DILATATION CATHETERS
Applicant: Cordis Corp.
PMA number: P880003
Supplement: S062
Product code: LOX
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Decision date: 1996-11-07
Decision code: APPR
Date received: 1996-08-21
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR QUARTER-SIZE BALLOONS ON THE VALOR AND VALOR XL PTCA DILATATION CATHETERS WHICH ARE INDICATED FOR BALLOON DILATATION OF THE STENOTIC PORTION O F A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPSOE OF IMPROVING MYOCARDIAL PERFUSION