Main information

  • Trade name:
  • Allure RF PM3222 - Biventricular pacemaker
  • Class:
  • AIMD
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device



  • Available in:
  • Allure RF PM3222 - Biventricular pacemaker
  • Language:
  • English

Other information


  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216290
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

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

Postal Address

17 Orion Road,LANE COVE, NSW, 2066


ARTG Start Date


Product category

Medical Device AIMD



Approval area

Medical Devices


- 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

Division USA

15900 Valley View Court

Sylmar, California, 91342

United States Of America


1. Allure RF PM3222 - Biventricular pacemaker

Product Type

Single Device Product

Effective date



47263 Biventricular pacemaker

Functional description

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.

Intended purpose

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.

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

Public Summary

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.

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