- Device
- Therapy Ablation Catheter (4mm and 8mm), Electrophysiology Cables (16, 17, 18 and 19 Series)
- Applicant
- Irvine Biomedical, Inc.
- PMA number
- P040014
- Supplement
- S047
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2022-12-16
- Decision code
- APPR
- Date received
- 2022-10-28
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for Sterigenics Utah as an alternate EO sterilization vendor for Irvine EP cables.