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
- S012
- 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
- January 12, 2026
- Date Received
- June 25, 2025
- Supplement Type
- Panel Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
- Docket Number
- FDA-0778
Advisory Committee Statement
for the FARAPULSE Pulsed Field Ablation System (FARAWAVE Pulsed Field Ablation Catheter, FARAWAVE NAV Pulsed Field Ablation Catheter, FARAPOINT 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, FARASTAR EGM to EP Recording System Cable FARAPOINT) to add the FARAPOINT Pulsed Field Ablation Catheter and the FARASTAR EGM to EP Recording System Cable. This device is indicated for:FARAWAVE and FARAWAVE NAV Pulsed Field Ablation CathetersThe FARAWAVE Catheter is indicated for: the isolation of pulmonary veins in the treatment of drug-refractory, recurrent, symptomatic Paroxysmal Atrial Fibrillation (PAF). 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).FARAPOINT Pulsed Field Ablation CatheterThe FARAPOINT Catheter is indicated for use as an adjunctive device for the creation of an ablation line between the inferior vena cava and the tricuspid valve when any FARAWAVE Catheter is used in the endocardial treatment of drug resistant, symptomatic persistent atrial fibrillation (episode duration no greater than 12 months).FARASTAR Pulsed Field Ablation GeneratorThe FARASTAR PFA Generator is intended for use with a compatible Boston Scientific PFA catheter in cardiac ablation procedures.FARASTAR Recording System ModuleThe FARASTAR Recording System Module (RSM) is indicated for use in an electrophysiology lab environment, as a filtering/protection unit to be connected between the patient and any attached recording systems and/or ECG systems, and as an interface for cardiac stimulation output.FARASTAR Catheter Connection CableThe FARASTAR Connection Cable is intended to be used with a FARAPULSE Catheter during an Electrophysiology procedure for cardiac tissue ablation.
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 |