PMA P880003S075

Device: NINJA PTCA DILATION CATHETERS
Applicant: Cordis Corp.
PMA number: P880003
Supplement: S075
Product code: LOX
Decision date: 1998-12-11
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Approval order statement: Approval for the Cordis Ninja PTCA Balloon Dilatation Catheters. The device is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis fo rth epurpose of improving myocardial perfusion.

Current openFDA PMA Record

Device: NINJA PTCA DILATION CATHETERS
Applicant: Cordis Corp.
PMA number: P880003
Supplement: S075
Product code: LOX
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Decision date: 1998-12-11
Decision code: APPR
Date received: 1998-06-01
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the Cordis Ninja PTCA Balloon Dilatation Catheters. The device is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis fo rth epurpose of improving myocardial perfusion.