FARAPULSE Pulsed Field Ablation System
FDA premarket approval P230030/S004 · decided 2024-05-03
Approval details
- PMA number
- P230030
- Supplement
- S004
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- 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
- 2024-04-19
- Decision date
- 2024-05-03
- Days to decision
- 14 days
- Decision code
- OK30
- Product code
- QZI
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Menlo Park, CA
- Statement
- a change to the electrical testing system of the FARASTAR generator used during manufacturing at the St. Paul facility
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.