PMA P880003S068

Device
TITAN MEGA AND TITAN MEGA XL PTCA DILATATION CATHETERS
Applicant
Cordis Corp.
PMA number
P880003
Supplement
S068
Product code
LOX
Decision date
1997-11-18
Generic name
Catheters, transluminal coronary angioplasty, percutaneous
Approval order statement
Approval for an additional marker band on the 10 mm balloon length of the THOR(TM) PTCA Dilatation Catheters.

Current openFDA PMA Record

Device
TITAN MEGA AND TITAN MEGA XL PTCA DILATATION CATHETERS
Applicant
Cordis Corp.
PMA number
P880003
Supplement
S068
Product code
LOX
Generic name
Catheters, transluminal coronary angioplasty, percutaneous
Decision date
1997-11-18
Decision code
APPR
Date received
1997-05-08
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for an additional marker band on the 10 mm balloon length of the THOR(TM) PTCA Dilatation Catheters.

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