PMA P880003S071

Device: CORDIS TITAN & TITAL XL DILATION CATHETERS
Applicant: Cordis Corp.
PMA number: P880003
Supplement: S071
Product code: LOX
Decision date: 1998-08-04
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Approval order statement: Approval for a new indication for use: the post-delivery expansion of the Palmaz-Schatz(TM) Coronary Stet, with the Titan(TM) and Tita(TM) XL PTCA Dilatation Catheters (3.0 mm, 3.25 mm, 3.5mm, 3.75 mm balloon diamters with 9 mm and 18 mm balloon lengths, and a 4.0 mm balloon diameter with 9 mm balloon length.)

Current openFDA PMA Record

Device: CORDIS TITAN & TITAL XL DILATION CATHETERS
Applicant: Cordis Corp.
PMA number: P880003
Supplement: S071
Product code: LOX
Generic name: Catheters, transluminal coronary angioplasty, percutaneous
Decision date: 1998-08-04
Decision code: APPR
Date received: 1997-07-17
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for a new indication for use: the post-delivery expansion of the Palmaz-Schatz(TM) Coronary Stet, with the Titan(TM) and Tita(TM) XL PTCA Dilatation Catheters (3.0 mm, 3.25 mm, 3.5mm, 3.75 mm balloon diamters with 9 mm and 18 mm balloon lengths, and a 4.0 mm balloon diameter with 9 mm balloon length.)