- Device
- CORDIS PTCA DILATATION CATHETERS AND CORDIS THOR PTCA DILATATION CATHETERS
- Applicant
- Cordis Corp.
- PMA number
- P880003
- Supplement
- S056
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 1996-04-23
- Decision code
- APPR
- Date received
- 1995-12-27
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR ADDITIONAL BALLOON SIZES FOR THE THOR PTCA DILATATION CATHETERS. THE ADDITIONAL BALLOON SIZES INCLUDE 2.75MM, 3.25MM, AND 3.75MM DIAMETERS AND 30MM LENGTHS