FARAPULSE Pulsed Field Ablation System (FARAWAVE Pulsed Field Ablation Catheter, FARASTAR Catheter Connection Cable,
FDA premarket approval P230030/S011 · decided 2025-04-03
Approval details
- PMA number
- P230030
- Supplement
- S011
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- FARAPULSE Pulsed Field Ablation System (FARAWAVE Pulsed Field Ablation Catheter, FARASTAR Catheter Connection Cable,
- Generic name
- Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
- Applicant
- Farapulse, Inc.
- Date received
- 2025-03-26
- Decision date
- 2025-04-03
- Days to decision
- 8 days
- Decision code
- OK30
- Product code
- QZI
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Menlo Park, CA
- Statement
- duplication of existing strut and electrode sub-assembly manufacturing line at the Coyol, Costa Rica site
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