Main information

  • Trade name:
  • AUTOGEN ICD VR – Model D175 - Defibrillator, implantable, automatic
  • Class:
  • AIMD
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device



  • Available in:
  • AUTOGEN ICD VR – Model D175 - Defibrillator, implantable, automatic
  • Language:
  • English

Other information


  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221628
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:


Boston Scientific Pty Ltd - AUTOGEN ICD VR ± Model D175 - Defibrillator, implantable, automatic

ARTG entry for

Medical Device Included AIMD


Boston Scientific Pty Ltd

Postal Address

PO Box 332,BOTANY, NSW, 1455


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.




Boston Scientific Corporation

4100 Hamline Avenue North

Saint Paul, MN, 55112

United States Of America


1. AUTOGEN ICD VR ± Model D175 - Defibrillator, implantable, automatic

Product Type

Medical device system

Effective date



35852 Defibrillator, implantable, automatic

Functional description

AUTOGEN VRÐsingle-chamber ICD provides combining ventricular tachyarrhythmia therapy with

ventricular pacing and sensing. Cardioversion/defibrillation therapies include a range of low- and

high-energy shocks using a biphasic waveform and choice of multiple shock vectors.

Intended purpose

Boston Scientific implantable cardioverter defibrillators (ICDs) are intended to provide ventricular

antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening

ventricular arrhythmias.

Variant information

Nil variant (as 1 device) N/A

Specific Conditions

No Specific Conditions included on Record

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Public Summary

Page 1 of

Produced at 10.11.2017 at 12:26:51 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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