- Device
- Therapy Ablation Catheter, Therapy 4mm Thermistor Ablation Catheter and Therapy Bi-Directional Ablation Catheter
- Applicant
- Irvine Biomedical, Inc.
- PMA number
- P040014
- Supplement
- S038
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2020-03-04
- Decision code
- OK30
- Date received
- 2020-02-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add a second sterilization cycle for previously sterilized product.