Platinium VR 1240 - Defibrillator, implantable, automatic

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

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Prenos Javno poročilo o oceni (PAR)
04-11-2017

Dostopno od:

Microport Crm Pty Ltd

Razred:

AIMD

Izdeluje:

MicroPort CRM S.r.l Via Crescentino sn, Saluggia, VC, 13040 Italy

Terapevtsko območje:

35852 - Defibrillator, implantable, automatic

Terapevtske indikacije:

The Platinium VR 1240 is a DF-4 configured single chamber implantable defibrillator, and is to be implanted in the patient for monitoring the patient's electrocardiogram (ECG). It is equipped with the RF wireless technology which enables remote monitoring of patients who have the Sorin SMARTVIEW monitor installed at home or wireless interrogation and device programming with the Orchestra Plus programmer equipped with Orchestra Plus Link accessory. PLATINIUM VR 1240 is an implantable single chamber cardioverter defibrillator with rate response, with the following indications - Patients who are survivors of cardiac arrest due to ventricular fibrillation or hemodynamically unstable sustained VT after evaluation to define the cause of the event and to exclude any completely reversible causes;Patients with structural heart disease and spontaneous sustained VT, whether hemodynamically stable or unstable; Patients with syncope of undetermined origin with clinically relevant hemodynamically significant sustained VT

Status dovoljenje:

Included

Opozorila o iskanju, povezana s tem izdelkom