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

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Medtronic Australasia Pty Ltd

Class:

Class III

Manufactured by:

Medtronic Inc 710 Medtronic Parkway, Minneapolis, MN, 55432 United States Of America

Therapeutic area:

61393 - Multi-purpose electrical stimulation system programmer

Therapeutic indications:

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.

Authorization status:

A

Authorization date:

2020-07-21