PMA P040042S049
- Device
- Therapy and Therapy Dual-8 and Safire TX Ablation Catheter
- Applicant
- Irvine Biomedical,Inc.(Ibi)
- PMA number
- P040042
- Supplement
- S049
- Product code
- OAD
- Decision date
- 2021-03-24
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Approval order statement
- Addition of an alternative bacterial endotoxin test method.
Current openFDA PMA Record#
- Device
- Therapy and Therapy Dual-8 and Safire TX Ablation Catheter
- Applicant
- Irvine Biomedical,Inc.(Ibi)
- PMA number
- P040042
- Supplement
- S049
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2021-03-24
- Decision code
- OK30
- Date received
- 2021-02-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of an alternative bacterial endotoxin test method.