Heartware Monitor - Circulatory assist system, software

国: オーストラリア

言語: 英語

ソース: Department of Health (Therapeutic Goods Administration)

即購入

公開評価報告書 公開評価報告書 (PAR)
03-11-2017

から入手可能:

Medtronic Australasia Pty Ltd

クラス:

Class III

製:

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

治療領域:

41578 - Circulatory assist system, software

適応症:

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.

認証ステータス:

A

承認日:

2017-07-13

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