Heartware Monitor - Circulatory assist system, software

Țară: Australia

Limbă: engleză

Sursă: Department of Health (Therapeutic Goods Administration)

Disponibil de la:

Medtronic Australasia Pty Ltd

Clasă:

Class III

Produs de:

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

Zonă Terapeutică:

41578 - Circulatory assist system, software

Indicații terapeutice:

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.

Statutul autorizaţiei:

A

Data de autorizare:

2017-07-13