RELIANCE

Main information

  • Trade name:
  • RELIANCE 4-FRONT G dual coil active fixation - Lead, defibrillator/pacemaker, implantable
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • RELIANCE 4-FRONT G dual coil active fixation - Lead, defibrillator/pacemaker, implantable
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217432
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217432

Boston Scientific Pty Ltd - RELIANCE 4-FRONT G dual coil active fixation - Lead, defibrillator/pacemaker,

implantable

ARTG entry for

Medical Device Included Class III

Sponsor

Boston Scientific Pty Ltd

Postal Address

PO Box 332,BOTANY, NSW, 1455

Australia

ARTG Start Date

18/11/2013

Product category

Medical Device Class III

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

Cardiac Pacemakers Incorporated (A wholly

owned subsidiary of Guidant Corporation A

wholly owned subsidiary of Boston Scientific

Corporation)

4100 Hamline Avenue

St Paul, Minnesota, 55112-5798

United States Of America

Products

1. RELIANCE 4-FRONT G dual coil active fixation - Lead, defibrillator/pacemaker, implantable

Product Type

Single Device Product

Effective date

18/11/2013

GMDN

36241 Lead, defibrillator/pacemaker, implantable

Functional description

RELIANCE 4-FRONT G dual coil active fixation are steroid eluting, endocardial cardioversion/defibrillation

and pace/sense lead that are intended for implantation as an integral part of an (ICD) or (CRT-D) system.

The lead conducts sensed intrinsic cardiac electrical signals from the heart to an implanted device and

delivers, as necessary, electrical pacing or cardioversion/defibrillation (shock) therapy from implanted

device to the heart.

Intended purpose

Intended for pacing, rate-sensing, and delivery of cardioversion and debrillation shocks when used with a

compatible pulse generator.

Variant information

Length (cm) 64

Length (cm) 70

Model number (see guidance docs) 0695

Model number (see guidance docs) 0696

Length (cm) 59

Model number (see guidance docs) 0658

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 08:29:38 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