CI-5245-xxx

Main information

  • Trade name:
  • CI-5245-xxx Naida CI Q70 (xxx denotes color) - Stimulator, electrical, auditory, cochlea
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • CI-5245-xxx Naida CI Q70 (xxx denotes color) - Stimulator, electrical, auditory, cochlea
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217677
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217677

Advanced Bionics Australia Pty Ltd - CI-5245-xxx Naida CI Q70 (xxx denotes color) - Stimulator, electrical,

auditory, cochlea

ARTG entry for

Medical Device Included Class III

Sponsor

Advanced Bionics Australia Pty Ltd

Postal Address

B2 / 12 Inglewood Place,BAULKHAM HILLS, NSW, 2153

Australia

ARTG Start Date

22/11/2013

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

Advanced Bionics AG

Laubisrutistrasse 28

Stafa, 8712,

Switzerland

Products

1. CI-5245-xxx Naida CI Q70 (xxx denotes color) - Stimulator, electrical, auditory, cochlea

Product Type

Single Device Product

Effective date

12/04/2016

GMDN

35643 Stimulator, electrical, auditory, cochlea

Functional description

The Naída CI sound processor is one part of a complete cochlear implant system that enables hearing.

The sound processor consists of two parts: the sound processor and battery power source. There are five

battery options, including three sizes of Lithium Ion rechargeable PowerCel™ batteries and a Zn-Air

Battery Pak.

Intended purpose

The Naída CI is a miniature computer that converts sound picked up by the microphone into electrical

signals that are used by the cochlear implant to enable hearing.

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 01:27:16 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

20-6-2018

Public Notification: XXXPlosion contains hidden drug ingredient

Public Notification: XXXPlosion contains hidden drug ingredient

The Food and Drug Administration is advising consumers not to purchase or use XXXPlosion, a product promoted for sexual enhancement. This product was identified by FDA during an examination of international mail shipments.

FDA - U.S. Food and Drug Administration

12-6-2018

Blokhuis: harde feiten gif in sigaretten zeer zorgelijk

Blokhuis: harde feiten gif in sigaretten zeer zorgelijk

Teer, nicotine en koolmonoxide gehalten in sigaretten die gemeten worden volgens de Canadian Intense (CI) methode zijn minimaal twee keer zo hoog als de gehalten gemeten met de wettelijke voorgeschreven ISO methode waarmee de EU en dus ook Nederland werkt. In sommige gevallen liggen de gehaltes zelfs tot meer dan 20 keer hoger. Dat blijkt uit onderzoek van het RIVM, dat 100 sigaretten onder de loep nam. Staatssecretaris Paul Blokhuis (VWS) heeft als opdrachtgever het onderzoek vandaag in ontvangst genome...

Netherlands - Ministerie van Volksgezondheid, Welzijn en Sport

There are no news related to this product.