PMA P880003S077

Device: CHARGER PTCA DILATION CATHETERS
Applicant: Cordis Corp.
PMA number: P880003
Supplement: S077
Product code: LOX
Decision date: 1998-11-16
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Approval order statement: Approval for the 18mm and 25mm length Charger PTCA catheters with 3.0mm, 3.5mm and 4.0mm balloon diameters. The 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: CHARGER PTCA DILATION CATHETERS
Applicant: Cordis Corp.
PMA number: P880003
Supplement: S077
Product code: LOX
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Decision date: 1998-11-16
Decision code: APPR
Date received: 1998-09-15
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the 18mm and 25mm length Charger PTCA catheters with 3.0mm, 3.5mm and 4.0mm balloon diameters. The 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.