Assurity+

Main information

  • Trade name:
  • Assurity+ PM1260 - Single-chamber pacemaker, rate-responsive
  • Class:
  • AIMD
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Assurity+ PM1260 - Single-chamber pacemaker, rate-responsive
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216286
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216286

St Jude Medical Australia Pty Ltd - Assurity+ PM1260 - Single-chamber pacemaker, rate-responsive

ARTG entry for

Medical Device Included AIMD

Sponsor

St Jude Medical Australia Pty Ltd

Postal Address

17 Orion Road,LANE COVE, NSW, 2066

Australia

ARTG Start Date

21/10/2013

Product category

Medical Device AIMD

Status

Active

Approval area

Medical Devices

Conditions

- 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.

Manufacturers

Name

Address

St Jude Medical Cardiac Rhythm Management

Division USA

15900 Valley View Court

Sylmar, California, 91342

United States Of America

Products

1. Assurity+ PM1260 - Single-chamber pacemaker, rate-responsive

Product Type

Single Device Product

Effective date

21/10/2013

GMDN

47267 Single-chamber pacemaker, rate-responsive

Functional description

The Assurity+ PM1260 is a single-chamber pulse generator with RF telemetry and patient notification

capability. 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+ PM1260 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.

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 http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 10.11.2017 at 05:24:21 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