Main information

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



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

Other information


  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218174
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:


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

ARTG entry for

Medical Device Included AIMD


Biotronik Australia Pty Ltd

Postal Address

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


ARTG Start Date


Product category

Medical Device AIMD



Approval area

Medical Devices


- 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.




Biotronik SE & Co KG

Woermannkehre 1

, Berlin, 12359



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

Product Type

Single Device Product

Effective date



35852 Defibrillator, implantable, automatic

Functional description

Ilesto 7 DR-T DF-4 ProMRI housing is made of biocompatible titanium, welded from outside and thus

hermetically sealed. The ellipsoid shape facilitates implantation in the pectoral muscle area. The

connections for bipolar pacing and sensing as well as for shock delivery are found in the device header.

Lead connectors are DF4/IS-1. Conditional MRI compatibility.

Intended purpose

Ilesto 7 DR-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 with ventricular pacing,

termination of spontaneous ventricular fibrillation, termination of spontaneous ventricular tachycardia,

compensation for 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

Public Summary

Page 1 of

Produced at 02.12.2017 at 04:48:16 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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There are no safety alerts related to this product.


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