Nerve-locating system, line-powered
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
09-11-2017
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Available from:
LMT Surgical Pty Ltd
Class:
Class IIa
Manufactured by:
Innovative Surgical Solutions LLC 21520 Bridge Street, Southfield, MI, 48033 United States Of America
Therapeutic area:
46456 - Nerve-locating system, line-powered
Therapeutic indications:
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.
Authorization status:
A
Authorization date:
2013-12-17
