PMA P040042
- Device
- Therapy™ Dual-8™ Ablation Catheter
- Applicant
- Irvine Biomedical,Inc.(Ibi)
- PMA number
- P040042
- Supplement
- S054
- Product code
- OAD
- Decision date
- 2026-09-03
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Approval order statement
- to add an alternate epoxy in the manufacture of the temperature sensor
Current openFDA PMA Record#
- Device
- Therapy™ Dual-8™ Ablation Catheter
- Applicant
- Irvine Biomedical,Inc.(Ibi)
- PMA number
- P040042
- Supplement
- S060
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2026-09-03
- Decision code
- OK30
- Date received
- 2026-08-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to add an alternate epoxy in the manufacture of the temperature sensor