Ilesto

Main information

  • Trade name:
  • Ilesto 7 HF-T DF-4 ProMRI - Defibrillator, implantable, automatic
  • Class:
  • AIMD
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Ilesto 7 HF-T DF-4 ProMRI - Defibrillator, implantable, automatic
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218175
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218175

Biotronik Australia Pty Ltd - Ilesto 7 HF-T DF-4 ProMRI - Defibrillator, implantable, automatic

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

6/12/2013

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. Ilesto 7 HF-T DF-4 ProMRI - Defibrillator, implantable, automatic

Product Type

Single Device Product

Effective date

6/12/2013

GMDN

35852 Defibrillator, implantable, automatic

Functional description

The housing made of biocompatible titanium & welded from outside is hermetically sealed. An ellipsoid

shape aids implantation in the pectoral muscle area. The connections for bipolar pacing and sensing (and

unipolar connections for the triple-chamber device) as well as for 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. DF4/IS-1 lead connectors. Conditional MRI compatibility.

Intended purpose

Ilesto 7 HF-T DF-4 is part of a family of implantable cardioverter-defibrillators. Primary objective of the

therapy is to prevent sudden cardiac death. Treating bradycardia arrhythmias and cardiac

resynchronization therapy with multisite ventricular pacing. Termination of spontaneous ventricular

fibrillation (VF) through shock delivery, termination of spontaneous ventricular tachycardia (VT), Cardiac

resynchronization through multisite ventricular pacing, compensation of bradycardia through AV sequential

pacing.

Variant information

Nil variant (as 1 device) Nil

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 02.12.2017 at 04:47:59 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

There are no safety alerts related to this product.

14-6-2018

Evaluation Plan Estimators

Evaluation Plan Estimators

Before you lodge your pre-submission planning form (PPF) you can use the below evaluation plan estimators to approximate the dates of the milestones in the prescription medicine registration process. The estimators derive dates representing an example...

Therapeutic Goods Administration - Australia