CI612 - Cochlear implant system electrode array assembly

Australia - English - Department of Health (Therapeutic Goods Administration)

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Available from:
Cochlear Ltd
Class:
AIMD
Authorization status:
Included
Authorization number:
322141

Public Summary

Summary for ARTG Entry:

322141

Cochlear Ltd - CI612 - Cochlear implant system electrode array assembly

ARTG entry for

Medical Device Included AIMD

Sponsor

Cochlear Ltd

Postal Address

1 University Avenue,MACQUARIE UNIVERSITY, NSW, 2109

Australia

ARTG Start Date

22/08/2019

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

Cochlear Ltd

1 University Avenue

MACQUARIE UNIVERSITY, NSW, 2109

Australia

Products

1. CI612 - Cochlear implant system electrode array assembly

Product Type

Single Device Product

Effective date

22/08/2019

GMDN

47373 Cochlear implant system electrode array assembly

Functional description

The CI612 cochlear implant is implanted in the mastoid region of either side or both sides of the head. The

cochlear implant receives electrical power and data from an external sound processor via electromagnetic

induction to the coil. The implanted magnet ensures that the external sound processor is correctly attached

and aligned relative to the implant coil.

Intended purpose

Intended for restoration of hearing sensation by electrical stimulation of the auditory nerve in patients with

moderately severe to profound sensorineural hearing loss.

Variant information

Nil variant (as 1 device) Nil

Specific Conditions

© 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 02.11.2019 at 06:20:14 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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