Cochlear

Main information

  • Trade name:
  • Cochlear implant system evaluation application software
  • Class:
  • (Export Only) Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Cochlear implant system evaluation application software
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217592
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217592

Cochlear Ltd - Cochlear implant system evaluation application software

ARTG entry for

Medical Device Included (Export Only) Class 1

Sponsor

Cochlear Ltd

Postal Address

1 University Avenue,MACQUARIE UNIVERSITY, NSW, 2109

Australia

ARTG Start Date

21/11/2013

Product category

Medical Device Class 1

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

Cochlear Ltd

1 University Avenue

MACQUARIE UNIVERSITY, NSW, 2109

Australia

Products

1. Cochlear implant system evaluation application software

Product Type

Single Device Product

Effective date

21/11/2013

GMDN

58734 Cochlear implant system evaluation application software

Intended purpose

Software or interface between the computer and the sound processor to enable programming of the

cochlear implant system.

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 01:45:13 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

18-3-2018

Medical Devices Safety Update Volume 6, Number 2, March 2018

Medical Devices Safety Update Volume 6, Number 2, March 2018

Preventable alarm issues; Review into cochlear implants; NHS cylinder alert; recent safety alerts

Therapeutic Goods Administration - Australia

There are no news related to this product.