PMA P890032S018
- Device
- Cordis Orion Steerable Ptca Balloon Catheter
- Applicant
- CORDIS CORP.
- PMA number
- P890032
- Supplement
- S018
- Decision date
- 1995-08-04
Current openFDA PMA Record
- Device
- CORDIS ORION STEERABLE PTCA BALLOON CATHETER
- Applicant
- Cordis Corp.
- PMA number
- P890032
- Supplement
- S018
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 1995-08-04
- Decision code
- APPR
- Date received
- 1993-12-20
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR:ALTERNATE STERILIZATION SITE; ELIMINATION OF CHLOROFLUOROCARBONS FROM THE STERILIZATION PROCESS