- Device
- HexaGen RF Generator Software and Remote
- Applicant
- Medtronic, Inc.
- PMA number
- P240013
- Supplement
- S026
- Product code
- QZI
- Generic name
- Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
- Decision date
- 2026-07-10
- Decision code
- APPR
- Date received
- 2026-04-13
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- the modifications to the HexaGen RF Generator (Model AFR-00004) Software and Remote USB Installer for the updated Remote Operating System.