Urodynamic measurement system
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
17-11-2017
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Available from:
Endotherapeutics Pty Ltd
Class:
Class IIa
Manufactured by:
Laborie Medical Technologies Inc Unit 10/6415 Northwest Drive, Missisauga, Ontario, L4V1X1 Canada
Therapeutic area:
14307 - Urodynamic measurement system
Therapeutic indications:
For diagnosis/study of the bladder. Measurement of urinary flow rate, urethral pressure, bladder capacity and response, and electromyogram (EMG) recording (the measurement of sphincter and other muscle activity. This is used to identify the cause of abnormal voiding, including incontinence and is useful for the diagnosis of, e.g. neurogenic bladder diseases, stress incontinence, urinary path obstruction or spastic sphincters.
Authorization status:
A
Authorization date:
2007-10-23
