- Device
- Safire TX Ablation Catheter, Therapy Dual 8 Ablation Catheter, Therapy 8MM Thermistor Ablation Catheter
- Applicant
- Irvine Biomedical,Inc.(Ibi)
- PMA number
- P040042
- Supplement
- S050
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2021-05-04
- Decision code
- OK30
- Date received
- 2021-04-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the flux used during soldering.