Reveal

Main information

  • Trade name:
  • Reveal LINQ Model LNQ11 - Implantable cardiac monitor
  • Class:
  • AIMD
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Reveal LINQ Model LNQ11 - Implantable cardiac monitor
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218791
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218791

Medtronic Australasia Pty Ltd - Reveal LINQ Model LNQ11 - Implantable cardiac monitor

ARTG entry for

Medical Device Included AIMD

Sponsor

Medtronic Australasia Pty Ltd

Postal Address

PO Box 945,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

23/12/2013

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

Medtronic Inc

710 Medtronic Parkway

Minneapolis, MN, 55432

United States Of America

Products

1. Reveal LINQ Model LNQ11 - Implantable cardiac monitor

Product Type

Medical device system

Effective date

23/12/2013

GMDN

47804 Implantable cardiac monitor

Functional description

The Medtronic Reveal LINQ ICM is a programmable device that continuously monitors a patient's ECG

and other physiological parameters. The device records cardiac information in response to automatically

detected arrhythmias and patient activation.

Intended purpose

The Reveal LINQ ICM is an insertable automatically-activated and patient-activated monitoring system that

records subcutaneous ECG.

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 09:19:44 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

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