FARAPULSE™ Pulsed Field Ablation System (FARAPULSE)
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- FARAPULSE Pulsed Field Ablation System (FARAWAVE Pulsed Field Ablation Catheter, FARASTAR Catheter Connection Cable, FDA PMA
- Generic Name
- Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation FDA PMA
Identifiers
- PMA Number
- P230030 FDA PMA
- FDA Product Code
- QZI FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Farapulse Pulsed Field Ablation System is a percutaneous cardiac ablation device designed for irreversible electroporation. It employs pulsed field ablation technology to create lesions in cardiac tissue, specifically targeting pulmonary vein isolation for the treatment of drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation (PAF).
The system comprises a catheter, generator, recording module, and associated cables, all used in an electrophysiology lab setting. Components are intended for single-use and are regulated under FDA PMA approval (P230030). The FARAWAVE Pulsed Field Ablation Catheter and FARASTAR Generator operate in conjunction for ablation, while the Recording System Module serves as a filtering/protection interface for ECG and stimulation outputs. Compliance with AAMI/IEC standards applies to certain cables.
Frequently asked questions
What is the primary clinical use of the FARAPULSE Pulsed Field Ablation System, and how does it differ from traditional ablation methods?
The FARAPULSE System is designed specifically for **irreversible electroporation** to isolate pulmonary veins during electrophysiology procedures, targeting **drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation (PAF)**. Unlike traditional radiofrequency or cryoablation, it uses pulsed electric fields to create precise lesions in cardiac tissue without thermal damage, potentially reducing collateral effects like charring or steam pops.
Is the FARAPULSE System intended for reuse, or is it single-use only? How should components be handled post-procedure?
All components of the FARAPULSE System—including the **FARAWAVE catheter, FARASTAR generator, cables, and recording module**—are explicitly **single-use only**. After a procedure, components must be discarded according to medical device biohazard protocols to ensure patient safety and prevent cross-contamination.
What key components make up the FARAPULSE System, and how do they work together during a procedure?
The system consists of four main parts: the **FARAWAVE catheter** (for tissue ablation), the **FARASTAR generator** (which delivers pulsed field energy), the **Recording System Module** (for ECG filtering and stimulation protection), and various **cables** (e.g., connection, EGM, stimulation). The catheter connects to the generator via cables, while the Recording System Module interfaces with external ECG/stimulation systems to ensure safe, filtered signal transmission during pulmonary vein isolation.
Are there specific storage requirements for the FARAPULSE System before use, and how should it be protected?
The system’s **single-use components** should be stored in their original, sealed packaging to maintain sterility and functionality. The packaging must remain unopened until immediately before use, and all parts should be kept in a clean, dry environment away from direct sunlight or extreme temperatures, as per standard medical device handling guidelines.
What regulatory pathway was followed for the FARAPULSE System, and what does this mean for clinicians using it?
The FARAPULSE System received **FDA Premarket Approval (PMA, P230030)**, indicating a rigorous review process for high-risk devices like Class III cardiac ablation tools. This approval confirms the system’s safety and effectiveness for its **intended use in pulmonary vein isolation for drug-refractory PAF**, though clinicians should adhere to the manufacturer’s instructions and institutional protocols for optimal outcomes.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: FARAPULSE - Pulsed Field Ablation System | Boston Scientific, FARAPULSE - Pulsed Field Ablation System - Boston Scientific, FARAPULSE™ Pulsed Field Ablation (PFA) System - Patient Information, Pulsed Field Ablation mit dem Farapulse PFA-System, Die Behandlung mit dem FARAPULSE™ PFA-System
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P230030 | Class III | Active |
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Manufacturer
- Manufacturer
- Farapulse Inc
- FDA Applicant
- Farapulse, Inc.
Sources (1)
- FDA PMA P230030 23 fields · synced Sep 18, 2026