External

Main information

  • Trade name:
  • External defibrillator electrode, adult, single-use
  • Class:
  • Class Is
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • External defibrillator electrode, adult, single-use
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218497
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218497

Zoll Medical Australia Pty Ltd - External defibrillator electrode, adult, single-use

ARTG entry for

Medical Device Included Class Is

Sponsor

Zoll Medical Australia Pty Ltd

Postal Address

Unit 10/39 Herbert Street,ST LEONARDS, NSW, 2065

Australia

ARTG Start Date

13/12/2013

Product category

Medical Device Class Is

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

Zoll Medical Corporation

269 Mill Road

Chelmsford, MA, 01824-4105

United States Of America

Products

1. External defibrillator electrode, adult, single-use

Product Type

Single Device Product

Effective date

13/12/2013

GMDN

44771 External defibrillator electrode, adult, single-use

Intended purpose

Sterile electrodes intended for use by qualified personnel who are trained in basic life support, or

advanced life support, or other physician-authorized emergency medical response for external

defibrillation, cardioversion, noninvasive pacing, and electrocardiograph monitoring.

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 10:15:24 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

25-2-2019

AEDs: How These Devices in Public Places Can Restart Hearts

AEDs: How These Devices in Public Places Can Restart Hearts

If cardiac arrest occurs, rapid treatment with a medical device called an automated external defibrillator, or 'AED' for short, can be life-saving. Learn how FDA works to help ensure they are safe and effective.

FDA - U.S. Food and Drug Administration

28-11-2018

EFSA Scientific Colloquium 24 – 'omics in risk assessment: state of the art and next steps

EFSA Scientific Colloquium 24 – 'omics in risk assessment: state of the art and next steps

Published on: Tue, 27 Nov 2018 In recent years, the development of innovative tools in genomics, transcriptomics, proteomics and metabolomics (designated collectively as 'omics technologies) has opened up new possibilities for applications in scientific research and led to the availability of vast amounts of analytical data. The interpretation and integration of 'omics data can provide valuable information on the functional status of an organism and on the effect of external factors such as stressors. T...

Europe - EFSA - European Food Safety Authority Publications

23-8-2018

Third external evaluation of EFSA – progress made, recommendations for improvement

Third external evaluation of EFSA – progress made, recommendations for improvement

Third external evaluation of EFSA – progress made, recommendations for improvement

Europe - EFSA - European Food Safety Authority Press Releases & News Stories

7-10-2016

Experts for the European Pharmacopoeia's groups of experts and working parties

Experts for the European Pharmacopoeia's groups of experts and working parties

A very large part of the work related to the drafting of new monographs for the European Pharmacopoeia (EDQM) is carried out by external experts in 75 groups of experts and working parties. Experts for the groups are appointed for a period of three years, and the EDQM is now seeking experts for the period from 2017 to 2019.

Danish Medicines Agency

28-2-2019

If a person has cardiac arrest, rapid treatment with a #medicaldevice called an automated external defibrillator (AED) can be life-saving. Here's how. link:  https://go.usa.gov/xEpzJ?utm_source=CDRHTwitterD … #heartmonthpic.twitter.com/fmj3uU8yb7

If a person has cardiac arrest, rapid treatment with a #medicaldevice called an automated external defibrillator (AED) can be life-saving. Here's how. link: https://go.usa.gov/xEpzJ?utm_source=CDRHTwitterD … #heartmonthpic.twitter.com/fmj3uU8yb7

If a person has cardiac arrest, rapid treatment with a #medicaldevice called an automated external defibrillator (AED) can be life-saving. Here's how. link: https://go.usa.gov/xEpzJ?utm_source=CDRHTwitterD … #heartmonth pic.twitter.com/fmj3uU8yb7

FDA - U.S. Food and Drug Administration

10-9-2018

 Architect/Building engineer - External expert contract - EMA/CEI/2018-2

Architect/Building engineer - External expert contract - EMA/CEI/2018-2

Europe - EMA - European Medicines Agency