- Device
- FARASTAR™ Pulsed Field Ablation (PFA) Generator; FARASTAR™ Mapping System Module (MSM); FARASTAR™ Recording System Modul
- Applicant
- Farapulse, Inc.
- PMA number
- P230030
- Supplement
- S013
- Product code
- QZI
- Generic name
- Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
- Decision date
- 2025-09-24
- Decision code
- APPR
- Date received
- 2025-06-26
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- approval for hardware, software and labeling changes to components of the FARAPULSE™ PFA System