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LUX-Dx II+ Insertable Cardiac Monitor - Implantable cardiac monitor - ARTG 466928

Access comprehensive regulatory information for LUX-Dx II+ Insertable Cardiac Monitor - Implantable cardiac monitor in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 466928 and sponsored by Boston Scientific Pty Ltd, manufactured by Cardiac Pacemakers Inc a subsidiary of Boston Scientific Corporation in United States of America. The device registration started on November 01, 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.

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TGA ARTG Official Data
Class III
ARTG 466928
Class III
LUX-Dx II+ Insertable Cardiac Monitor - Implantable cardiac monitor
ARTG ID: 466928
Good Name: Boston Scientific Pty Ltd - LUX-Dx II+ Insertable Cardiac Monitor - Implantable cardiac monitor
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Intended Purpose

The LUX-Dx Insertable Cardiac Monitor (ICM) is intended to monitor and record subcutaneous ECG (S-ECG) for the clinical evaluation and diagnosis of cardiac arrhythmias

Device Classification
Risk Class
Class III
Product Type
Procedure Pack
ARTG Category
General
Registration Information
ARTG ID
466928
Start Date
November 01, 2024
Effective Date
November 01, 2024
Manufacturer
Country
United States of America
Address
4100 Hamline Avenue North, St Paul, Minnesota, 55112-5798