Nerve-locating system, line-powered
Land: Australien
Sprog: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
Offentlige vurderingsrapport
(PAR)
09-11-2017
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Tilgængelig fra:
LMT Surgical Pty Ltd
Klasse:
Class IIa
Fremstillet af:
Innovative Surgical Solutions LLC 21520 Bridge Street, Southfield, MI, 48033 United States Of America
Terapeutisk område:
46456 - Nerve-locating system, line-powered
Terapeutiske indikationer:
The device consists of a control unit, power supply, sensor harness and user manual packaged together as a system. The device is intended for use in surgical procedures to assist the surgeon in locating and mapping motor nerves through the use of mechanomyographic (MMG) signals and electrical stimulus of nerves. The device is indicated for locating and identifying spinal nerce roots and peripheral motor nerves originating from spinal nerves C3-T1 and L2-S2.
Autorisation status:
A
Autorisation dato:
2013-12-17
