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myLUX Mobile Device - Implantable cardiac device management application software - ARTG 472726

Access comprehensive regulatory information for myLUX Mobile Device - Implantable cardiac device management application software in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 472726 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 December 11, 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 472726
Class III
myLUX Mobile Device - Implantable cardiac device management application software
ARTG ID: 472726
Good Name: Boston Scientific Pty Ltd - myLUX Mobile Device - Implantable cardiac device management application software
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Intended Purpose

Software app that is installed on non-medical off-the-shelf mobile devices and function by collecting and transmitting event, patient, and device data. The patient app is intended primarily for patient use.

Device Classification
Risk Class
Class III
Product Type
Procedure Pack
ARTG Category
General
Registration Information
ARTG ID
472726
Start Date
December 11, 2024
Effective Date
December 11, 2024
Manufacturer
Country
United States of America
Address
4100 Hamline Avenue North, St Paul, Minnesota, 55112-5798