Allure RF PM3222 - Biventricular pacemaker

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

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Javno poročilo o oceni Javno poročilo o oceni (PAR)
19-07-2023

Dostopno od:

Abbott Medical Australia Pty Ltd

Razred:

Class III

Izdeluje:

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

Terapevtsko območje:

47263 - Biventricular pacemaker

Terapevtske indikacije:

The Allure PM3222 is a CRT-P with RF telemetry, patient notification capability and Corvue congestion monitoring. This device can be programmed with a Merlin Patient Care System and has device header with IS-1 connector for connection of unipolar or bipolar IS-1 leads. The Allure PM3222 is intended for patients who would benefit from resynchronization of the right and left ventricles or have one or more conventional indications for the implantation of a pacemaker. 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:

2022-12-14

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