PMA P880003S053

Device: CORDIS PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) DILATATION CATHETERS
Applicant: Cordis Corp.
PMA number: P880003
Supplement: S053
Product code: LOX
Decision date: 1996-04-12
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Approval order statement: APPROVAL FOR A MODIFIED VERSION OF THE TRAKSTAR 14 PTCA DILATATION CATHETER. AS MODIFIED THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME CORDIS THOR PTCA DILATATION CATHETER

Current openFDA PMA Record

Device: CORDIS PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) DILATATION CATHETERS
Applicant: Cordis Corp.
PMA number: P880003
Supplement: S053
Product code: LOX
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Decision date: 1996-04-12
Decision code: APPR
Date received: 1995-12-04
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A MODIFIED VERSION OF THE TRAKSTAR 14 PTCA DILATATION CATHETER. AS MODIFIED THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME CORDIS THOR PTCA DILATATION CATHETER