PMA P880003S079

Device: RAPTOR PTCA DILATATION CATHETER
Applicant: Cordis Corp.
PMA number: P880003
Supplement: S079
Product code: LOX
Decision date: 2000-04-27
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Approval order statement: Approval for the Raptor PTCA Catheter (balloon diameters ranging from 1.5 mm to 5.0 mm with lengths ranging from 10 mm to 35 mm).

Current openFDA PMA Record

Device: RAPTOR PTCA DILATATION CATHETER
Applicant: Cordis Corp.
PMA number: P880003
Supplement: S079
Product code: LOX
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Decision date: 2000-04-27
Decision code: APPR
Date received: 1999-10-01
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for the Raptor PTCA Catheter (balloon diameters ranging from 1.5 mm to 5.0 mm with lengths ranging from 10 mm to 35 mm).