Summary for ARTG Entry:
St Jude Medical Australia Pty Ltd - Allure RF PM3222 - Biventricular pacemaker
ARTG entry for
Medical Device Included AIMD
St Jude Medical Australia Pty Ltd
17 Orion Road,LANE COVE, NSW, 2066
ARTG Start Date
Medical Device AIMD
- 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. Allure RF PM3222 - Biventricular pacemaker
Single Device Product
47263 Biventricular pacemaker
The Allure PM3222 is a CRT-P with RF telemetry, patient notification capability and Corvue congestion
monitoring. This device can be programmed with a Merlin Patient Care System and has device header
with IS-1 connector for connection of unipolar or bipolar IS-1 leads.
The Allure PM3222 is intended for patients who would benefit from resynchronization of the right and left
ventricles or have one or more conventional indications for the implantation of a pacemaker. Also AT/AF
detection algorithm is indicated for detecting atrial tachyarrhythmias which have been found to be
associated with an increased risk of stroke in elderly, hypertensive, pacemaker patients without prior
history of AF.
Nil variant (as 1 device) N/A
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 05:23:18 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