Ilivia 7 HF-T QP - Biventricular pacemaker/defibrillator

Australia - English - Department of Health (Therapeutic Goods Administration)

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Available from:
Biotronik Australia Pty Ltd
Class:
AIMD
Authorization status:
Included
Authorization number:
290410

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Public Summary

Summary for ARTG Entry:

290410

Biotronik Australia Pty Ltd - Ilivia 7 HF-T QP - Biventricular pacemaker/defibrillator

ARTG entry for

Medical Device Included AIMD

Sponsor

Biotronik Australia Pty Ltd

Postal Address

Suite 2 Level 4 Building 2,20 Bridge Street,PYMBLE, NSW, 2073

Australia

ARTG Start Date

19/06/2017

Product category

Medical Device AIMD

Status

Active

Approval area

Medical Devices

Conditions

- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,

Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations

2002 for relevant information.

- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal

offence; and civil penalties may apply.

Manufacturers

Name

Address

Biotronik SE & Co KG

Woermannkehre 1

, Berlin, 12359

Germany

Products

1. Ilivia 7 HF-T QP - Biventricular pacemaker/defibrillator

Product Type

Single Device Product

Effective date

19/06/2017

GMDN

47270 Biventricular pacemaker/defibrillator

Functional description

An implantable ICD; triple chamber; IS4 port connecting a quadripolar LV lead, rate adaptive, Home

Monitoring, max shock of 40J, IS-1/IS4/DF4 connector (MR conditional). Biocompatible titanium housing is

hermetically sealed; ellipsoid shape helps implanting in the pectoral muscle. Connections for bipolar

pacing, sensing; unipolar connections; & shock delivery are in the header. The housing serves as a

potential antipole during shock delivery or in the case of unipolar lead configuration.

Intended purpose

Ilivia 7 HF-T QP belongs to a family of implantable cardioverter-defibrillators (ICDs). The primary objective

of the therapy is to prevent sudden cardiac death. Furthermore, the device is capable of

treating bradycardia arrhythmias and cardiac resynchronization therapy with multisite ventricular pacing.

The implantation of an ICD is a symptomatic therapy with the following objectives: Termination of

spontaneous ventricular fibrillation (VF) through shock delivery; Termination of spontaneous ventricular

tachycardia (VT) through antitachycardia pacing (ATP); in case of ineffective ATP or haemodynamically

not tolerated VT, with shock delivery; Cardiac resynchronization through multisite ventricular pacing;

Compensation of bradycardia through AV sequential pacing. Triple-chamber ICDs are indicated for

patients with the following risks: Sudden cardiac death caused by ventricular arrhythmias; Congestive

heart failure with ventricular asynchrony.

Variant information

Model number (see guidance docs) 404621

Specific Conditions

No Specific Conditions included on Record

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

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Produced at 01.12.2017 at 11:47:27 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

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