FARASTAR Pulsed Field Ablation (PFA) Generator; FARASTAR Mapping System Module (MSM); FARASTAR Recording System Modul
FDA premarket approval P230030/S013 · decided 2025-09-24
Approval details
- PMA number
- P230030
- Supplement
- S013
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- FARASTAR Pulsed Field Ablation (PFA) Generator; FARASTAR Mapping System Module (MSM); FARASTAR Recording System Modul
- Generic name
- Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
- Applicant
- Farapulse, Inc.
- Date received
- 2025-06-26
- Decision date
- 2025-09-24
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- QZI
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Menlo Park, CA
- Statement
- approval for hardware, software and labeling changes to components of the FARAPULSE PFA System
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