Main information

  • Trade name:
  • Smartview Monitor PSTN - Pacemaker programmer
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device



  • Available in:
  • Smartview Monitor PSTN - Pacemaker programmer
  • Language:
  • English

Other information


  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217759
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:


LivaNova Australia Pty Ltd - Smartview Monitor PSTN - Pacemaker programmer

ARTG entry for

Medical Device Included Class III


LivaNova Australia Pty Ltd

Postal Address

16 - 18 Hydrive Close,South Dandenong, VIC, 3175


ARTG Start Date


Product category

Medical Device Class III



Approval area

Medical Devices


- 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.




Sorin Group Italia SRL

Via Crescentino sn 13040 Saluggia VC



1. Smartview Monitor PSTN - Pacemaker programmer

Product Type

Single Device Product

Effective date



15993 Pacemaker programmer

Functional description

The Smartview PSTN (Public Switched Telephone Network) model KA970 is part of the Smartview remote

monitoring system, specifically designed to transmit information stored in the cardiac device to the

physician. The cardiac device is equipped with a transmitter which sends information and device

parameters through the monitor using radio frequency wireless technology. The data retrieved by the

monitor is routed through the phone network, converted to a format that is reported to the physician.

Intended purpose

The Smartview PSTN monitor is designed for use with the Sorin radio frequency implanted cardiac device

only and any household traditional (analog type) telephone land line specifically to transmit information

stored in the implanted cardiac device to the physician.

Variant information

Nil variant (as 1 device) 0

Specific Conditions

No Specific Conditions included on Record

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written approval from the Commonwealth.Further details can be found at

Public Summary

Page 1 of

Produced at 10.11.2017 at 01:07:22 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.

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