Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
Basic Information
- Device Name
- Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
- Trade Name
- FARAPULSE Pulsed Field Ablation System (FARAWAVE Pulsed Field Ablation Catheter, FARAWAVE NAV Pulsed Field Ablation C
- PMA Number
- P230030
- Supplement Number
- S007
- Device Class
- FDA Class 3
- Product Code
- QZI
- Generic Name
- Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- July 3, 2025
- Date Received
- November 25, 2024
- Supplement Type
- Panel Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee 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 Module Y-Cable Short, FARASTAR Recording System Module Catheter Pin Cable, FARASTAR Recording System Module ECG Trunk Cable, FARASTAR Recording System Module ECG Output Module (AAMI/IEC), FARASTAR Recording System Module EGM Input Module, FARASTAR SNAP CABLE R/L (AAMI/IEC), FARASTAR SNAP CABLE V SET (AAMI), FARASTAR SNAP CABLE C SET (IEC), FARASTAR Recording System Module ECG Output to Rhythmia HDx ECG Input Cable, FARASTAR Recording System Module EGM Output to Rhythmia HDx EGM Input Cable, FARASTAR Mapping System Module Back Patch Cable, FARASTAR Mapping System Module Back Patch Cable Male, FARASTAR Mapping System Module BNC BNC-Phono Cable, FARASTAR Mapping System Module Rhythmia ABL Cable, FARASTAR Mapping System Module Auxiliary Cable) for expanding the indications to include the isolation of pulmonary veins and the posterior wall in the treatment of drug-refractory, symptomatic Persistent Atrial Fibrillation (episode duration less than one year).
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QZI | Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation | FDA class 3 | Unknown |