Nucleus 7 Sound Processor (CP1000) - Cochlear implant system sound processor

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

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Available from:
Cochlear Ltd
Class:
Class III
Authorization status:
Included
Authorization number:
292000

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Public Summary

Summary for ARTG Entry:

292000

Cochlear Ltd - Nucleus 7 Sound Processor (CP1000) - Cochlear implant system sound processor

ARTG entry for

Medical Device Included Class III

Sponsor

Cochlear Ltd

Postal Address

1 University Avenue,MACQUARIE UNIVERSITY, NSW, 2109

Australia

ARTG Start Date

25/07/2017

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. Nucleus 7 Sound Processor (CP1000) - Cochlear implant system sound processor

Product Type

Single Device Product

Effective date

25/07/2017

GMDN

47374 Cochlear implant system sound processor

Functional description

The Nucleus 7 Sound Processor (CP1000) is used together with a cochlear implant to transmit sound to

the cochlea (inner ear).

Intended purpose

Restoration of hearing sensation via the digital processing of sound to deliver through a cochlear implant

electrical stimulation of the auditory nerve.

Variant information

Nil variant (as 1 device) Nil

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 03.11.2017 at 10:44:53 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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