PMA P880003S061

Device: THOR PTCA DILATION CATHETERS
Applicant: Cordis Corp.
PMA number: P880003
Supplement: S061
Product code: LOX
Decision date: 1997-01-17
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Approval order statement: APPROVAL FOR A MODIFIED INNER BODY MATERIAL, AN OPTIONAL GUIDEWIRE LUMEN COATING, AN OPTIONAL TIP LENGTH, OPTIONAL DUAL MARKER BANDS, AND A SIX-PLEAT BALLOON FOLDING PROCESS ON THE TITAN AND TITAN XL PTCA DILATATION CATHETERS.

Current openFDA PMA Record

Device: THOR PTCA DILATION CATHETERS
Applicant: Cordis Corp.
PMA number: P880003
Supplement: S061
Product code: LOX
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Decision date: 1997-01-17
Decision code: APPR
Date received: 1996-07-23
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A MODIFIED INNER BODY MATERIAL, AN OPTIONAL GUIDEWIRE LUMEN COATING, AN OPTIONAL TIP LENGTH, OPTIONAL DUAL MARKER BANDS, AND A SIX-PLEAT BALLOON FOLDING PROCESS ON THE TITAN AND TITAN XL PTCA DILATATION CATHETERS.