Allure

Main information

  • Trade name:
  • Allure RF PM3222 - Biventricular pacemaker
  • Class:
  • AIMD
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Allure RF PM3222 - Biventricular pacemaker
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216290
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216290

St Jude Medical Australia Pty Ltd - Allure RF PM3222 - Biventricular pacemaker

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. Allure RF PM3222 - Biventricular pacemaker

Product Type

Single Device Product

Effective date

21/10/2013

GMDN

47263 Biventricular pacemaker

Functional description

The Allure PM3222 is a CRT-P with RF telemetry, patient notification capability and Corvue congestion

monitoring. 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 Allure PM3222 is intended for patients who would benefit from resynchronization of the right and left

ventricles or have one or more conventional indications for the implantation of a pacemaker. 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 05:23:18 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

18-9-2018

Xtava recalls Allure and Allure Pro 2200W ionic ceramic hair dryers

Xtava recalls Allure and Allure Pro 2200W ionic ceramic hair dryers

The hair dryer and power cord can overheat and catch on fire, posing fire, burn and electrical shock hazards.

Health Canada

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