- Device
- Safire™ TX Bi-directional and Therapy™ Dual-8™
- Applicant
- Irvine Biomedical,Inc.(Ibi)
- PMA number
- P040042
- Supplement
- S058
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2026-01-15
- Decision code
- OK30
- Date received
- 2025-12-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an alternate vapor degreaser which is used as a processing aid to remove metalworking cutting fluid on patient-contacting tip electrodes and electrode rings during manufacturing