AUTOGEN

Main information

  • Trade name:
  • AUTOGEN CRT-D Model G172 - Defibrillator, implantable, automatic
  • Class:
  • AIMD
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • AUTOGEN CRT-D Model G172 - Defibrillator, implantable, automatic
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221615
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221615

Boston Scientific Pty Ltd - AUTOGEN CRT-D Model G172 - Defibrillator, implantable, automatic

ARTG entry for

Medical Device Included AIMD

Sponsor

Boston Scientific Pty Ltd

Postal Address

PO Box 332,BOTANY, NSW, 1455

Australia

ARTG Start Date

24/03/2014

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

Boston Scientific Corporation

4100 Hamline Avenue North

Saint Paul, MN, 55112

United States Of America

Products

1. AUTOGEN CRT-D Model G172 - Defibrillator, implantable, automatic

Product Type

Medical device system

Effective date

24/03/2014

GMDN

35852 Defibrillator, implantable, automatic

Functional description

CRT-Ds provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of

life-threatening ventricular arrhythmias through a range of low- and high-energy shocks using a biphasic

waveform and choice of multiple shock vectors.

Intended purpose

Boston Scientific Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for patients

with heart failure who receive stable optimal pharmacologic therapy (OPT) for heart failure and who meet

any one of the following classifications:

· Moderate to severe heart failure (NYHA Class III-IV) with EF ? 35% and QRS duration ? 120 ms

· Left bundle branch block (LBBB) with QRS duration ? 130 ms, EF ? 30%, and mild (NYHA Class II)

ischemic or nonischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure

Boston Scientific CRT-Ds are also intended to provide ventricular antitachycardia pacing 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

© 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 23.11.2017 at 12:27:38 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