Summary for ARTG Entry:
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
St Jude Medical Australia Pty Ltd
17 Orion Road,LANE COVE, NSW, 2066
ARTG Start Date
Medical Device Class III
- 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.
St Jude Medical Cardiac Rhythm Management
15900 Valley View Court
Sylmar, California, 91342
United States Of America
1. Optisure DF4, Passive Fixation, Dual Coil Leads models LDP220Q & LDP230Q - Lead,
Single Device Product
36241 Lead, defibrillator/pacemaker, implantable
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.
For use with compatible pulse generators to provide pacing, sensing and deliver cardioversion /
defibrillation therapy to the heart.
Model number (see guidance docs) LDP230Q
Electrode spacing on lead/catheter 17-21cm
Length (cm) 52-65
Model number (see guidance docs) LDP220Q
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 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