PMA P230030S012

Device

FARAPULSE™ Pulsed Field Ablation System (FARAWAVE™ Pulsed Field Ablation Catheter, FARAWAVE™ NAV Pulsed Field Ablation C

Applicant

Farapulse, Inc.

PMA number

P230030

Supplement

S012

Product code

QZI

Decision date

2026-01-12

Classification

Cardiovascular

Generic name

Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation

Approval order 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.