Optimizer IVs Implantable Pulse Generator (IPG) - Cardiac contractility modulation system pulse generator

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)
07-11-2017

から入手可能:

Impulse Dynamics (Australia) Pty Ltd

クラス:

AIMD

製:

Impulse Dynamics NV Schottegatweg Oost 10 Unit AIK, Curacao, Dutch Caribbean Netherlands

治療領域:

47468 - Cardiac contractility modulation system pulse generator

適応症:

A programmable device with internal rechargeable battery and telemetry functions, normally implanted in the right pectoral region. The system monitors the Heart's intrinsic activity and delivers cardiac contractility modulation (CCM) signals during the ventricular absolute refractory period. The Optimizer IVs Implantable Pulse Generator (IPG) is indicated for use in patients who are older than 18 years of age with symptomatic heart failure due to systolic left ventricular dysfunction despite appropriate medical therapy. The Optimizer IVs IPG delivers non-excitatory CCM signals to the heart and has no pacemaker or ICD functions.

認証ステータス:

A

承認日:

2015-01-19

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