Heartware Monitor - Circulatory assist system, software

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

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Javno poročilo o oceni Javno poročilo o oceni (PAR)
03-11-2017

Dostopno od:

Medtronic Australasia Pty Ltd

Razred:

Class III

Izdeluje:

HeartWare Inc 14400 NW 60th Avenue, Miami Lakes, Florida, 33014 United States Of America

Terapevtsko območje:

41578 - Circulatory assist system, software

Terapevtske indikacije:

The HeartWare Monitor is a touch screen tablet PC computer that uses proprietary software to display system performance information and permits adjustment of selected controller parameters. When connected to a controller, the monitor receives continuous blood pump information from the controller and displays real-time and historical pump information. The monitor also displays alarm conditions. The HeartWare Monitor is an external component of the HeartWare Ventricular Assist System? (HVAD?) for the treatment of heart failure. The monitor is used to display HVAD? system performance and to change controller/LVAD operating parameters.

Status dovoljenje:

A

Datum dovoljenje:

2017-07-13

Opozorila o iskanju, povezana s tem izdelkom