Pneumatic/ultrasonic lithotripsy system probe
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
01-11-2019
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Available from:
Life Healthcare Pty Ltd
Class:
Class IIa
Manufactured by:
EMS Electro Medical Systems SA Chemin De La Vuarpilliere 31, NYON, 1260 Switzerland
Therapeutic area:
64380 - Pneumatic/ultrasonic lithotripsy system probe
Therapeutic indications:
Probe intended to be used in conjunction with the lithotriptor to send ultrasound and pressure waves, either together or alternatively, to stones in the urinary tract (kidney, ureter and bladder), breaking stones down and removing them through its lumen by suction. This is a sterile, single-use device.
Authorization status:
A
Authorization date:
2019-09-03
