Summary for ARTG Entry:
Biotronik Australia Pty Ltd - Ilesto 7 HF-T DF-4 ProMRI - Defibrillator, implantable, automatic
ARTG entry for
Medical Device Included AIMD
Biotronik Australia Pty Ltd
Suite 2 Level 4 Building 2,20 Bridge Street,PYMBLE, NSW, 2073
ARTG Start Date
Medical Device AIMD
- 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
, Berlin, 12359
1. Ilesto 7 HF-T DF-4 ProMRI - Defibrillator, implantable, automatic
Single Device Product
35852 Defibrillator, implantable, automatic
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.
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
Nil variant (as 1 device) Nil
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.
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