- Device
- FIRE STAR RX PTCA BALLOON DILATATION CATHETER
- Applicant
- Cordis Corp.
- PMA number
- P880003
- Supplement
- S097
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 2009-11-05
- Decision code
- APPR
- Date received
- 2009-06-09
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR THE ADDITION OF CORDIS DE MEXICO AS AN ALTERNATE MANUFACTURER OF THE BALLOON COMPONENT FOR THE DEVICE.