PMA P880003S057

Device: CORDIS PTCA DILATATION CATHETER, TITAN AND TITAN XL PTCA DILATATION CATHETERS
Applicant: Cordis Corp.
PMA number: P880003
Supplement: S057
Product code: LOX
Decision date: 1996-05-06
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Approval order statement: APPROVAL FOR 1)TITAN AND TITAN XL PTCA DILATATION CATHETERS WITH 4.5MM AND 5.0MM DIAMETER BALLOONS AVAILABLE IN 20MM LENGTHS; AND 2)A MODIFIED HUB BONDING PROCESS

Current openFDA PMA Record

Device: CORDIS PTCA DILATATION CATHETER, TITAN AND TITAN XL PTCA DILATATION CATHETERS
Applicant: Cordis Corp.
PMA number: P880003
Supplement: S057
Product code: LOX
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Decision date: 1996-05-06
Decision code: APPR
Date received: 1996-01-16
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR 1)TITAN AND TITAN XL PTCA DILATATION CATHETERS WITH 4.5MM AND 5.0MM DIAMETER BALLOONS AVAILABLE IN 20MM LENGTHS; AND 2)A MODIFIED HUB BONDING PROCESS