Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Medtronic Australasia Pty Ltd - TH90DXX Handset with Communicator - Multi-purpose electrical stimulation
ARTG entry for
Medical Device Included Class III
Medtronic Australasia Pty Ltd
PO Box 945, NORTH RYDE BC, NSW, 1670
ARTG Start Date
Medical Device Class III
- 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
- 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.
710 Medtronic Parkway
Minneapolis, MN, 55432
United States Of America
1 . TH90DXX Handset with Communicator - Multi-purpose electrical stimulation system programmer
Medical device system
61393 Multi-purpose electrical stimulation system programmer
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.
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.
Nil variant (as 1 device) N/A
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.
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