TH90DXX Handset with Communicator - Multi-purpose electrical stimulation system programmer
देश: ऑस्ट्रेलिया
भाषा: अंग्रेज़ी
स्रोत: Department of Health (Therapeutic Goods Administration)
सार्वजनिक आकलन रिपोर्ट
(PAR)
22-07-2020
अनुरोध भेजा।
थमां उपलब्ध:
Medtronic Australasia Pty Ltd
वर्ग:
Class III
द्वारा बनाया गया:
Medtronic Inc 710 Medtronic Parkway, Minneapolis, MN, 55432 United States Of America
चिकित्सीय क्षेत्र:
61393 - Multi-purpose electrical stimulation system programmer
चिकित्सीय संकेत:
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.
प्राधिकरण का दर्जा:
A
प्राधिकरण की तारीख:
2020-07-21
