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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceFARAPULSE™ Pulsed Field Ablation System (FARAWAVE™ Pulsed Field Ablation Catheter, FARASTAR™ Catheter Connection Cable,
Generic NamePercutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation
ApplicantFARAPULSE, Inc.
3715 Haven Avenue
Suite 110
Menlo Park, CA 94025
PMA NumberP230030
Date Received09/15/2023
Decision Date01/30/2024
Product Code QZI 
Advisory Committee Cardiovascular
Clinical TrialsNCT04612244
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
approval for the FARAPULSE™ Pulsed Field Ablation System (FARAWAVE™ Pulsed Field Ablation Catheter, FARASTAR™ Catheter Connection Cable, FARASTAR™ Pulsed Field Ablation Generator, FARASTAR™ Recording System Module, FARASTAR™ Stimulation Module Cable, FARASTAR™ EGM Cable, FARASTAR™ Stimulation Module Male Cable, FARASTAR™ Stimulation Module Female 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 (AAMI/IEC), FARASTAR™ Recording System Module ECG Output Cable (AAMI/IEC), FARASTAR™ Recording System Module EGM Input Module, FARASTAR™ SNAP CABLE R/L – (AAMI/IEC), FARASTAR™ SNAP CABLE V SET – (AAMI/IEC)). This device is indicated for:FARAWAVE™ Pulsed Field Ablation Catheter: The FARAWAVE Catheter is indicated for the isolation of pulmonary veins in the treatment of drug-refractory, recurrent, symptomatic Paroxysmal Atrial Fibrillation (PAF).FARASTAR™ Pulsed Field Ablation Generator: The FARASTAR PFA Generator when used in conjunction with the FARAWAVE PFA Catheter, is indicated for the isolation of pulmonary veins in the treatment of drug-refractory, recurrent, symptomatic Paroxysmal Atrial Fibrillation (PAF).FARASTAR™ Recording System Module: The 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 Cable: The FARASTAR Connection Cable is intended to be used with a FARAPULSE Catheter during an Electrophysiology procedure for cardiac tissue ablation
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S004 
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