Heartware Monitor - Circulatory assist system, software

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Disponível em:

Medtronic Australasia Pty Ltd

Classe:

Class III

Fabricado por:

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

Área terapêutica:

41578 - Circulatory assist system, software

Indicações terapêuticas:

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 de autorização:

A

Data de autorização:

2017-07-13