Optimizer Mini Charger System - Implant battery charger

Ülke: Avustralya

Dil: İngilizce

Kaynak: Department of Health (Therapeutic Goods Administration)

Mevcut itibaren:

Impulse Dynamics (Australia) Pty Ltd

Sınıf:

Class III

Tarafından üretildi:

Impulse Dynamics (USA) Inc 50 Lake Center Suite 100, Marlton, NJ, 08053 United States Of America

Terapötik alanı:

33658 - Implant battery charger

Terapötik endikasyonlar:

The Optimizer Mini Charger is intended to recharge the OPTIMIZER IPG transcutaneously by inductive power transfer and has been designed to permit recharging with minimal patient interaction. The Optimizer Mini Charger System includes the OPTIMIZER Mini charger Kit 10-F202-3-XX and the Mini Charger/Wand 13-100-002. The charger is powered by a rechargeable battery, and the kit is supplied with a AC Adapter to recharge the internal battery. The Optimizer Mini Charger System is for recharging the battery located in the Optimizer Implantable Pulse Generator (IPG). The Optimizer IPG System 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 IPG delivers non-excitatory CCM signals to the heart and has no pacemaker or ICD functions.

Yetkilendirme durumu:

A

Yetkilendirme tarihi:

2018-05-23