TH90DXX Handset with Communicator - Multi-purpose electrical stimulation system programmer

Australia - English - Department of Health (Therapeutic Goods Administration)

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Available from:
Medtronic Australasia Pty Ltd
Class:
Class III
Authorization status:
Included
Authorization number:
339925

Public Summary

Summary for ARTG Entry:

339925

Medtronic Australasia Pty Ltd - TH90DXX Handset with Communicator - Multi-purpose electrical stimulation

system programmer

ARTG entry for

Medical Device Included Class III

Sponsor

Medtronic Australasia Pty Ltd

Postal Address

PO Box 945, NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

21/07/2020

Product Category

Medical Device Class III

Status

Active

Approval Area

Medical Devices

Conditions

- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5, Division 2

(Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations 2002 for

relevant information.

- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal offence;

and civil penalties may apply.

Manufacturers

Name

Address

Medtronic Inc

710 Medtronic Parkway

Minneapolis, MN, 55432

United States Of America

Products

1 . TH90DXX Handset with Communicator - Multi-purpose electrical stimulation system programmer

Product Type

Medical device system

Effective Date

21/07/2020

GMDN

61393 Multi-purpose electrical stimulation system programmer

Functional

Description

The TH90DXX Kit contains the TM90 Communicator that is intended for use with the non-medical COTS handset (HH90 Samsung

Smart phone). The Activa Patient Programmer App A620 is used to view and adjust DBS therapy within clinician-defined limits for

the Medtronic Activa neurostimulator for DBS Therapy connecting to the implanted device through the TM90 Communicator. The

XX indicates the intended country to meet electrical safety standards.

Intended Purpose

The Medtronic TH90D Kit contains the TM90 Communicator and the HH90 Handset. The Activa Patient Programmer App A620 is

intended to be used for viewing and adjusting DBS therapy within clinician-defined limits. The app is installed on and used with the

handset using the TM90 Communicator to connect with the implanted neurostimulator.

Variant information

Nil variant (as 1 device) N/A

Specific Conditions

No Specific Conditions included on Record

© Commonwealth of Australia. This work is copyright. You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth. Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 22.07.2020 at 07:59:20 AEST

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

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