PMA P880003S063

Device: VALOR AND VALOR XL PTCA DILATATION CATHETERS
Applicant: Cordis Corp.
PMA number: P880003
Supplement: S063
Product code: LOX
Decision date: 1996-11-20
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Approval order statement: APPROVAL FOR VALOR AND VALOR XL PTCA DILATATION CATHETERS WITH 10MM AND 15MM BALLOON LENGTHS INDICATED FOR BALLOON DIALTATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION

Current openFDA PMA Record

Device: VALOR AND VALOR XL PTCA DILATATION CATHETERS
Applicant: Cordis Corp.
PMA number: P880003
Supplement: S063
Product code: LOX
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Decision date: 1996-11-20
Decision code: APPR
Date received: 1996-09-03
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR VALOR AND VALOR XL PTCA DILATATION CATHETERS WITH 10MM AND 15MM BALLOON LENGTHS INDICATED FOR BALLOON DIALTATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION