Intica 7 HF-T - 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:
290411

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Public Summary

Summary for ARTG Entry:

290411

Biotronik Australia Pty Ltd - Intica 7 HF-T - 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. Intica 7 HF-T - Biventricular pacemaker/defibrillator

Product Type

Single Device Product

Effective date

19/06/2017

GMDN

47270 Biventricular pacemaker/defibrillator

Functional description

This is a triple chamber, rate adaptive ICD with home monitoring functions. Max shock energy 40J,

IS-1/DF-1 connector. The housing is biocompatible titanium and hermetically sealed. The ellipsoid shape

facilitates implantation in the pectoral muscle area. The connections for bipolar pacing, sensing and shock

delivery are found in the device header. The housing serves as a potential antipole during shock delivery

or in the case of unipolar lead configuration. MRI compatibility is

conditional.

Intended purpose

Intica 7 HF-T belongs to a family of implantable cardioverter-defibrillators(ICD). 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 hemodynamically 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) 404627

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

Page 1 of

Produced at 01.12.2017 at 11:47:11 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.

Visit www.tga.gov.au for contact information

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