Endurity PM2160 - Dual-chamber pacemaker, rate-responsive

Available from:

Abbott Medical Australia Pty Ltd

Class:

AIMD

Manufactured by:

St Jude Medical Cardiac Rhythm Management Division 15900 Valley View Court, Sylmar, California, 91342 United States Of America

Therapeutic area:

47265 - Dual-chamber pacemaker, rate-responsive

Therapeutic indications:

The Endurity PM2160 is a dual-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 PM2160 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.

Authorization status:

A

Authorization date:

2013-10-21