PMA P880003S081

Device: NC NINJA PTCA DILATATION CATHETER
Applicant: Cordis Corp.
PMA number: P880003
Supplement: S081
Product code: LOX
Decision date: 2000-09-21
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Approval order statement: APPROVAL FOR THE NC RAPTOR PTCA CATHETER (BALLOON DIAMETERS RANGING FROM 2.25 MM TO 4.0 MM AND LENGTHS RANGING FROM 10 MM TO 30 MM). THE NC RAPTOR PTCA CATHETER IS INDICATED FOR BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION. MODELS WITH THE FOLLOWING BALLOON SIZES (LENGTH X DIAMETER) ARE ALSO INDICATED FOR THE POST-DELIVERY EXPANSION OF BALLOON EXPANDABLE STENTS: 2.25 MM X 10 MM TO 15 MM; 3.0 MM X 20 MM TO 30 MM; AND 4.0 MM X 15 MM TO 30 MM.

Current openFDA PMA Record

Device: NC NINJA PTCA DILATATION CATHETER
Applicant: Cordis Corp.
PMA number: P880003
Supplement: S081
Product code: LOX
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Decision date: 2000-09-21
Decision code: APPR
Date received: 1999-10-12
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE NC RAPTOR PTCA CATHETER (BALLOON DIAMETERS RANGING FROM 2.25 MM TO 4.0 MM AND LENGTHS RANGING FROM 10 MM TO 30 MM). THE NC RAPTOR PTCA CATHETER IS INDICATED FOR BALLOON DILATATION OF THE STENOTIC PORTION OF A CORONARY ARTERY OR BYPASS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION. MODELS WITH THE FOLLOWING BALLOON SIZES (LENGTH X DIAMETER) ARE ALSO INDICATED FOR THE POST-DELIVERY EXPANSION OF BALLOON EXPANDABLE STENTS: 2.25 MM X 10 MM TO 15 MM; 3.0 MM X 20 MM TO 30 MM; AND 4.0 MM X 15 MM TO 30 MM.