PMA P880003S080

Device: NINJA FX PTCA DILATATION CATHETER
Applicant: Cordis Corp.
PMA number: P880003
Supplement: S080
Product code: LOX
Decision date: 2000-07-07
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Approval order statement: APPROVAL FOR NINJA(FX) PTCA DILATATION CATHETER WITH THE FOLLOWING BALLOON SIZES: 1.5 MM X 20 MM, 25 MM, AND 30 MM; 2.0 MM X 20 MM, 25 MM, AND 30 MM; 2.25 MM - 4.0 MM (IN 1/4 MM SIZES) X 10 MM, 15 MM, 18MM, 20 MM, 25 MM, AND 30 MM; 4.5 MM X 20 MM; AND 5.0 MM X 20 MM. THE NINJA(FX) PTCA DILATATINO 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.

Current openFDA PMA Record

Device: NINJA FX PTCA DILATATION CATHETER
Applicant: Cordis Corp.
PMA number: P880003
Supplement: S080
Product code: LOX
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Decision date: 2000-07-07
Decision code: APPR
Date received: 1999-10-07
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR NINJA(FX) PTCA DILATATION CATHETER WITH THE FOLLOWING BALLOON SIZES: 1.5 MM X 20 MM, 25 MM, AND 30 MM; 2.0 MM X 20 MM, 25 MM, AND 30 MM; 2.25 MM - 4.0 MM (IN 1/4 MM SIZES) X 10 MM, 15 MM, 18MM, 20 MM, 25 MM, AND 30 MM; 4.5 MM X 20 MM; AND 5.0 MM X 20 MM. THE NINJA(FX) PTCA DILATATINO 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.