PMA P880003S074

Device: CHARGER PTCA DILATATION CATHETERS
Applicant: Cordis Corp.
PMA number: P880003
Supplement: S074
Product code: LOX
Decision date: 1998-08-10
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Approval order statement: Approval for addition of 1.5 mm and 2.0 mm balloon diamters with 20, 30 and 40 mm balloon lenghts, and 4.5 mm and 5.0 mm balloon diameters with 20 mm balloon length to the Charger(TM) PTCA Dilatation Catheter line.

Current openFDA PMA Record

Device: CHARGER PTCA DILATATION CATHETERS
Applicant: Cordis Corp.
PMA number: P880003
Supplement: S074
Product code: LOX
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Decision date: 1998-08-10
Decision code: APPR
Date received: 1998-05-13
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for addition of 1.5 mm and 2.0 mm balloon diamters with 20, 30 and 40 mm balloon lenghts, and 4.5 mm and 5.0 mm balloon diameters with 20 mm balloon length to the Charger(TM) PTCA Dilatation Catheter line.