Fortify Assura DR CD2359-40QC - Defibrillator, implantable, automatic

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

Kupite ga zdaj

Prenos Javno poročilo o oceni (PAR)
11-11-2017

Dostopno od:

Abbott Medical Australia Pty Ltd

Razred:

AIMD

Izdeluje:

St Jude Medical Cardiac Rhythm Management Division 15900 Valley View Court, Sylmar, California, 91342 United States Of America

Terapevtsko območje:

35852 - Defibrillator, implantable, automatic

Terapevtske indikacije:

The Fortify Assura DR CD2359-40QC is a dual chamber implantable cardioverter defibrillator (ICD) with RF telemetry and it monitors and regulates a patient's heart rate by providing ventricular tachyarrhythmia therapy. It features a DF4 device header and Parylene coating. The Fortify Assura DR CD2359-40QC is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. Also AT/AF detection algorithm is indicated for detecting atrial tachyarrhythmias which have been found to be associated with an increased risk of stroke in elderly, hypertensive, pacemaker patients without prior history of AF. This device is MRI conditional.

Status dovoljenje:

A

Datum dovoljenje:

2013-03-19

Opozorila o iskanju, povezana s tem izdelkom