- Device
- Safire™ TX Ablation Catheter, Safire™ TX, Catheter Extension Cable, Therapy™ Dual-8™ Ablation Catheter, Cables 16- 17- 1
- Applicant
- Irvine Biomedical,Inc.(Ibi)
- PMA number
- P040042
- Supplement
- S056
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2024-10-15
- Decision code
- OK30
- Date received
- 2024-09-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a change to the bioburden alert and action limits used at the Irvine, California manufacturing facility