FARAPULSE Pulsed Field Ablation System (FARAWAVE Pulsed Field Ablation Catheter, FARAWAVE NAV Pulsed Field Ablation C
FDA premarket approval P230030/S007 · decided 2025-07-03
Approval details
- PMA number
- P230030
- Supplement
- S007
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- FARAPULSE Pulsed Field Ablation System (FARAWAVE Pulsed Field Ablation Catheter, FARAWAVE NAV Pulsed Field Ablation C
- Generic name
- Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
- Applicant
- Farapulse, Inc.
- Date received
- 2024-11-25
- Decision date
- 2025-07-03
- Days to decision
- 220 days
- Decision code
- APPR
- Product code
- QZI
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Menlo Park, CA
- Statement
- approval for the FARAPULSE Pulsed Field Ablation System (FARAWAVE Pulsed Field Ablation Catheter, FARAWAVE NAV Pulsed Field Ablation Catheter, FARASTAR Catheter Connection Cable, FARASTAR Pulsed Field Ablation Generator, FARASTAR Recording System Module, FARASTAR Mapping System Module, FARASTAR Stimulation Module Cable, FARASTAR EGM Cable, FARASTAR Stimulation Module Male Cable, FARASTAR Stimulation Module Female Cable, FARASTAR Stimulation Module Y-Cable Long, FARASTAR Stimulation
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