Main information

  • Trade name:
  • Assurity PM2240 - Dual-chamber pacemaker, rate-responsive
  • Class:
  • AIMD
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device



  • Available in:
  • Assurity PM2240 - Dual-chamber pacemaker, rate-responsive
  • Language:
  • English

Other information


  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216285
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:


St Jude Medical Australia Pty Ltd - Assurity PM2240 - Dual-chamber pacemaker, rate-responsive

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. Assurity PM2240 - Dual-chamber pacemaker, rate-responsive

Product Type

Single Device Product

Effective date



47265 Dual-chamber pacemaker, rate-responsive

Functional description

The Assurity PM2240 is a dual-chamber pulse generator with RF telemetry. 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 Assurity PM2240 pulse generator is intended to be implanted when a patient has one or more of the

following permanent conditions: syncope, presyncope, fatigue, disorientation due to

arrhythmia/bradycardia, or a combination of these symptoms. It monitors and regulates a patient's heart

rate by providing bradycardia therapy and dual-chamber pacing. 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

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written approval from the Commonwealth.Further details can be found at

Public Summary

Page 1 of

Produced at 10.11.2017 at 05:24:38 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.

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