Smartview

Main information

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

Documents

Localization

  • Available in:
  • Smartview Monitor GPRS - Pacemaker programmer
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217760
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217760

LivaNova Australia Pty Ltd - Smartview Monitor GPRS - Pacemaker programmer

ARTG entry for

Medical Device Included Class III

Sponsor

LivaNova Australia Pty Ltd

Postal Address

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

Australia

ARTG Start Date

26/11/2013

Product category

Medical Device Class III

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

Sorin Group Italia SRL

Via Crescentino sn 13040 Saluggia VC

Italy

Products

1. Smartview Monitor GPRS - Pacemaker programmer

Product Type

Single Device Product

Effective date

26/11/2013

GMDN

15993 Pacemaker programmer

Functional description

The Smartview GPRS model KA971 is a radio frequency wireless monitor that collects clinical information

and and device parameters. The data is retrieved by the portable external monitor from the cardiac device

and is routed through the cellular network, converted to a format that can be reported to the physician

Intended purpose

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

defibrillator 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

© 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 01:07:06 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