FARAPULSE Pulsed Field Ablation System
FDA premarket approval P230030/S002 · decided 2024-06-18
Approval details
- PMA number
- P230030
- Supplement
- S002
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- FARAPULSE Pulsed Field Ablation System
- Generic name
- Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
- Applicant
- Farapulse, Inc.
- Date received
- 2024-02-28
- Decision date
- 2024-06-18
- Days to decision
- 111 days
- Decision code
- APPR
- Product code
- QZI
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Menlo Park, CA
- Statement
- approval of the protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P230030
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