Neurophysiologic monitoring system
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
01-12-2017
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Available from:
Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes
Class:
Class IIa
Manufactured by:
Synthes GmbH 3 Eimattstrasse, Oberdorf, 4436 Switzerland
Therapeutic area:
46566 - Neurophysiologic monitoring system
Therapeutic indications:
A series of individual components intended for use in intraoperative procedures for patient-connected intraoperative neuromonitoring where an appropriate neuromonitoring machine is also used. The components transmit energy from a neuromonitoring machine that allows for triggered EMG stimulation and subsequent recording of the stimulus from the muscle whose nerve was initially stimulated.
Authorization status:
A
Authorization date:
2013-12-09
