Battery

Main information

  • Trade name:
  • Battery, secondary
  • Class:
  • (Export Only) Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Battery, secondary
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219968
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219968

Cochlear Ltd - Battery, secondary

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

7/02/2014

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. Battery, secondary

Product Type

Single Device Product

Effective date

7/02/2014

GMDN

34158 Battery, secondary

Intended purpose

This device is to generate the electrical power to the speech processor.

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 05:51:20 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

5-11-2018

STIHL Limited recalls STIHL MSA 161 T Battery Operated Arborist Chain Saw

STIHL Limited recalls STIHL MSA 161 T Battery Operated Arborist Chain Saw

The side inter-lock button may stick when gripping the machine, which could cause the throttle trigger to remain depressed and the chain to continue to run even after releasing the throttle trigger. This can pose a risk of laceration to the user or bystander.

Health Canada

11-10-2018

Cooper Lighting LLC Recalls All-Pro and Defiant Solar/Battery Powered Light Fixtures

Cooper Lighting LLC Recalls All-Pro and Defiant Solar/Battery Powered Light Fixtures

The batteries in the solar-powered light fixtures can overheat and cause the light fixture's housing to melt, posing a fire hazard.

Health Canada

18-7-2018

London Drugs Limited recalls Apex Premium LED Lighting Set

London Drugs Limited recalls Apex Premium LED Lighting Set

The battery box of the affected product may melt when the lights are turned on, posing fire and burn hazards.

Health Canada

7-6-2018

Abbott Medical ICDs and CRT-Ds

Abbott Medical ICDs and CRT-Ds

Hazard alert - firmware update to improve battery performance and cybersecurity

Therapeutic Goods Administration - Australia

1-11-2018

The @US_FDA issues a letter to health care providers regarding possible battery failure in Getinge's Maquet/Datascope intra-aortic balloon pumps. Read the letter here:  https://go.usa.gov/xPyHT  #MedicalDevice

The @US_FDA issues a letter to health care providers regarding possible battery failure in Getinge's Maquet/Datascope intra-aortic balloon pumps. Read the letter here: https://go.usa.gov/xPyHT  #MedicalDevice

The @US_FDA issues a letter to health care providers regarding possible battery failure in Getinge's Maquet/Datascope intra-aortic balloon pumps. Read the letter here: https://go.usa.gov/xPyHT  #MedicalDevice

FDA - U.S. Food and Drug Administration