PMA P040042S047
- Device
- Therapy Dual 8 and Therapy 8mm Tip Thermistor Ablation Catheter
- Applicant
- Irvine Biomedical,Inc.(Ibi)
- PMA number
- P040042
- Supplement
- S047
- Product code
- OAD
- Decision date
- 2020-10-16
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Approval order statement
- Alternative batch sampling for bacterial endotoxin testing.
Current openFDA PMA Record#
- Device
- Therapy Dual 8 and Therapy 8mm Tip Thermistor Ablation Catheter
- Applicant
- Irvine Biomedical,Inc.(Ibi)
- PMA number
- P040042
- Supplement
- S047
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2020-10-16
- Decision code
- OK30
- Date received
- 2020-09-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternative batch sampling for bacterial endotoxin testing.