Optisure

Main information

  • Trade name:
  • Optisure DF4, Passive Fixation, Dual Coil Leads models LDP220Q & LDP230Q - Lead, defibrillator/pacemaker, implantable
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Optisure DF4, Passive Fixation, Dual Coil Leads models LDP220Q & LDP230Q - Lead, defibrillator/pacemaker, implantable
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221013
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221013

St Jude Medical Australia Pty Ltd - Optisure DF4, Passive Fixation, Dual Coil Leads models LDP220Q &

LDP230Q - Lead, defibrillator/pacemaker, implantable

ARTG entry for

Medical Device Included Class III

Sponsor

St Jude Medical Australia Pty Ltd

Postal Address

17 Orion Road,LANE COVE, NSW, 2066

Australia

ARTG Start Date

11/03/2014

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

St Jude Medical Cardiac Rhythm Management

Division USA

15900 Valley View Court

Sylmar, California, 91342

United States Of America

Products

1. Optisure DF4, Passive Fixation, Dual Coil Leads models LDP220Q & LDP230Q - Lead,

defibrillator/pacemaker, implantable

Product Type

Single Device Product

Effective date

11/03/2014

GMDN

36241 Lead, defibrillator/pacemaker, implantable

Functional description

For attachment to an implantable cardioverter defibrillator (ICD) with DF4 device header configuration. The

leads have two defibrillation electrodes on in the distal portion to provide true bipolar rate sensing, pacing

and delivery of cardioversion/defibrillation shocks.

Intended purpose

For use with compatible pulse generators to provide pacing, sensing and deliver cardioversion /

defibrillation therapy to the heart.

Variant information

Model number (see guidance docs) LDP230Q

Electrode spacing on lead/catheter 17-21cm

Length (cm) 52-65

Model number (see guidance docs) LDP220Q

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 10.11.2017 at 02:28:35 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