- Device
- CORDIS PTCA DILATATION CATHETER AND CORDIS VALOR AND VALOR XL PTCA DILATATION CATHETERS
- Applicant
- Cordis Corp.
- PMA number
- P880003
- Supplement
- S055
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 1996-04-23
- Decision code
- APPR
- Date received
- 1995-12-13
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A MODIFIED VERSION OF THE TRAKSTAR 14 PTCA DILATATION CATHETER - THE DEVICE AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAME CORDIS VALOR AND VALOR XL PTCA DILATATION CATHETER