- Device
- TITAN AND TITAN XL PTCA DILATATION CATHETERS
- Applicant
- Cordis Corp.
- PMA number
- P880003
- Supplement
- S052
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 1996-03-13
- Decision code
- APPR
- Date received
- 1995-11-22
- 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 3.25MM AND 3.75MM DIAMETER BALLOONS AVAILABLE IN 9MM OR 18MM LENGTHS 2)A MODIFIED HUB BONDING PROCESS 3)A CHANGE IN THE DEVICE NAME FROM TITAN 18 PTCA DILATATION CATHEGTERS TO TITAN PTCA DILATATION CATHETERS 4)ONE SET OF INSTRUCTION FOR USE FOR ALL TITAN AND TITAN XL PTCA DILATATION CATHETERS