Optimizer IV System Mini Charger Kit ? Model 10-F201-3-XX - Cardiac contractility modulation system charger

מדינה: אוסטרליה

שפה: אנגלית

מקור: Department of Health (Therapeutic Goods Administration)

זמין מ:

Impulse Dynamics (Australia) Pty Ltd

סיווג:

Class III

תוצרת:

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

איזור תרפויטי:

47466 - Cardiac contractility modulation system charger

סממני תרפויטית:

The Optimizer Mini Charger System is a charger powered by a rechargeable battery. The system includes a permanently attached charging wand. The device is supplied with an AC Adapter to recharge the internal battery. The charger is designed to permit recharging with only minimal patient interaction. It is intended to recharge the OPTIMIZER IVs IPG transcutaneously by inductive power transfer. As part of the Optimizer IVs System, the Optimizer IVs Charger is for recharging the battery located in the Optimizer IVs Implantable Pulse Generator (IPG). The Optimizer IVs 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 IVs IPG delivers non-excitatory CCM signals to the heart and has no pacemaker or ICD functions.

מצב אישור:

A

תאריך אישור:

2015-06-02