- Device
- FARASTAR™ Pulsed Field Ablation (PFA) Generator; FARASTAR™ Mapping System Module (MSM); FARASTAR™ Recording System Modul
- Applicant
- Farapulse, Inc.
- PMA number
- P230030
- Supplement
- S024
- Product code
- QZI
- Generic name
- Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
- Decision date
- 2026-09-04
- Decision code
- APPR
- Date received
- 2026-06-30
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for FARASTAR PFA Generator Software 4.5.3/4.6.3, FARASTAR Foot Switch, and updates to the FARASTAR System Instructions for Use