Quadra Assura MP CD3371-40C - Defibrillator, implantable, automatic

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

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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 Quadra Assura MP CD3371-40C is a cardiac resynchronisation therapy device with RF telemetry and it monitors and regulates the patient?s heart rate by providing ventricular tachyarrhythmia therapy and quadripolar pacing with Multi Site Pacing. It features an IS-1/DF-1 device header and Parylene coating. The Quadra Assura MP CD3371-40C is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. Cardiac Resynchronization Therapy devices (CRT-Ds) are also intended to resynchronize the right and left ventricles in patients with congestive heart failure. 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.

Status dovoljenje:

A

Datum dovoljenje:

2013-03-19

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