Cochlear Nucleus Replacement Magnet Cassette - Cochlear implant implantable magnet

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

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Available from:
Cochlear Ltd
Class:
Class III
Authorization status:
Included
Authorization number:
322144

Public Summary

Summary for ARTG Entry:

322144

Cochlear Ltd - Cochlear Nucleus Replacement Magnet Cassette - Cochlear implant implantable magnet

ARTG entry for

Medical Device Included Class III

Sponsor

Cochlear Ltd

Postal Address

1 University Avenue,MACQUARIE UNIVERSITY, NSW, 2109

Australia

ARTG Start Date

22/08/2019

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

Cochlear Ltd

1 University Avenue

MACQUARIE UNIVERSITY, NSW, 2109

Australia

Products

1. Cochlear Nucleus Replacement Magnet Cassette - Cochlear implant implantable magnet

Product Type

Single Device Product

Effective date

22/08/2019

GMDN

62601 Cochlear implant implantable magnet

Functional description

Holds the coil of the external sound processor firmly against the recipient's head via magnetic attraction,

and thus provides correct alignment between the implant coil and sound processor coil to ensure efficient

power and data transfer.

Intended purpose

To replace an implantable magnet cassette, or temporary non-magnetic cassette after MRI examinations,

in order to allow external sound processor coils to be magnetically attached and aligned with the cochlear

implant coil.

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 06:19:11 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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