Quadra Allure MP RF PM3262 - Biventricular pacemaker

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

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Prenos 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 Quadra Allure MP RF PM3262 is a CRT-P with RF telemetry which monitors and regulates the patient's heart rate through dual chamber bradycardia pacing and improve ventricular resynchronization through biventricular pacing. It is a quadripolar device with MultiPoint Pacing and provides the option to select from 4 left ventricular pacing electrodes and 14 pacing vectors. The Quadra Allure MP RF PM3262 is intended to be implanted when a patient has one or more of the following permanent conditions: syncope, presyncope, fatigue, disorientation due to arrhythmia/bradycardia, or any combination of these symptoms. The implantation of Quadra Allure MP RF PM3262 is also intended for patients who would benefit from resynchronisation of the right and left ventricles or have one or more conventional indications for the implantation of a pacemaker. Also the Quadra Allure MP RF PM3262 is indicated for patients who exhibit sick sinus syndrome, chronic symptomatic second-degree and third-degree AV block, recurrent Adam-Stokes syndrome and symptomatic bilateral bundle branch block when tachyarrhythmia and other causes have been ruled out.

Status dovoljenje:

A

Datum dovoljenje:

2022-12-14

Opozorila o iskanju, povezana s tem izdelkom