Heart-lung bypass system
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
19-10-2022
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Available from:
LivaNova Australia Pty Ltd
Class:
Class IIb
Manufactured by:
LivaNova Deutschland GmbH Lindberghstr 25, Munchen, 80939 Germany
Therapeutic area:
35099 - Heart-lung bypass system
Therapeutic indications:
The Essenz Heart-Lung Machine is intended to perform, control, monitor and support extracorporeal blood circulation replacing the mechanical pumping function of the heart, monitoring and regulating physiologic parameters during procedures requiring extracorporeal circulation.
Authorization status:
A
Authorization date:
2022-07-25
