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
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. Assurity PM2240 - Dual-chamber pacemaker, rate-responsive
Single Device Product
47265 Dual-chamber pacemaker, rate-responsive
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.
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.
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 05:24:38 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.
Visit www.tga.gov.au for contact information