Australia TGA ARTG record

TRUPULSE Generator - Cardiac irreversible electroporation system generator

Australia TGA ARTG Registered Device · Johnson & Johnson Medical Pty Ltd · Biosense Webster Inc · Class IIb · Started April 08, 2024

Good Name: Johnson & Johnson Medical Pty Ltd - TRUPULSE Generator - Cardiac irreversible electroporation system generator

Device classification

Risk Class: Class IIb
Product Type: Medical device system
ARTG Category: General

Registration information

Start Date: April 08, 2024
Effective Date: April 08, 2024

Sponsor

Name: Johnson & Johnson Medical Pty Ltd

Manufacturer

Name: Biosense Webster Inc
Country: United States of America
Address: 31 Technology Drive Suite 200, Irvine, California, 92618

Intended purpose

The generator is intended for cardiac electrophysiology procedures. It delivers pulsed field (PF) ablation during cardiac ablation procedures.

About this record

Access comprehensive regulatory information for TRUPULSE Generator - Cardiac irreversible electroporation system generator in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Johnson & Johnson Medical Pty Ltd, manufactured by Biosense Webster Inc in United States of America. The device registration started on April 08, 2024.

This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.