Summary for ARTG Entry:
St Jude Medical Australia Pty Ltd - Endurity PM1160 - Single-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. Endurity PM1160 - Single-chamber pacemaker, rate-responsive
Single Device Product
47267 Single-chamber pacemaker, rate-responsive
The Endurity PM1160 is a single-chamber, inductive pulse generator. 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 Endurity PM1160 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 single-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
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