FARAWAVE Pulsed Field Ablation Catheter, FARAWAVE NAV Pulsed Field Ablation Catheter, FARASTAR Pulsed Field Ablation
FDA premarket approval P230030/S003 · decided 2024-10-18
Approval details
- PMA number
- P230030
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- FARAWAVE Pulsed Field Ablation Catheter, FARAWAVE NAV Pulsed Field Ablation Catheter, FARASTAR Pulsed Field Ablation
- Generic name
- Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
- Applicant
- Farapulse, Inc.
- Date received
- 2024-04-05
- Decision date
- 2024-10-18
- Days to decision
- 196 days
- Decision code
- APPR
- Product code
- QZI
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Menlo Park, CA
- Statement
- approval for new and updated components of the FARAPULSE Pulsed Field Ablation (PFA) System, including the FARAWAVE Catheter, FARASTAR Mapping System Module, FARASTAR Generator, and FARASTAR Recording System Module
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.