PMA P880003S064
- Device
- Titan Mega And Titan Mega Xl
- Applicant
- CORDIS CORP.
- PMA number
- P880003
- Supplement
- S064
- Decision date
- 1997-02-10
Current openFDA PMA Record
- Device
- TITAN MEGA AND TITAN MEGA XL
- Applicant
- Cordis Corp.
- PMA number
- P880003
- Supplement
- S064
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 1997-02-10
- Decision code
- APPR
- Date received
- 1996-09-16
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR TITAN MEGA AND TITAN MEGA XL PTCA DILATATION CATHETERS. THESE CATHETERS ARE INDICATED FOR BALLOON DILATATION OF TH ESTENOTIC PORTION OF A COARONARY ARTERY OR BYAPSS GRAFT STENOSIS FOR THE PURPOSE OF IMPROVING MYOCARDIAL PERFUSION.