Cuff

Main information

  • Trade name:
  • Cuff, blood pressure, single use
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Cuff, blood pressure, single use
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219807
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219807

Edwards Lifesciences Pty Ltd - Cuff, blood pressure, single use

ARTG entry for

Medical Device Included Class 1

Sponsor

Edwards Lifesciences Pty Ltd

Postal Address

PO Box 137,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

3/02/2014

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

Edwards Lifesciences LLC

One Edwards Way

Irvine, California, 92614

United States Of America

Products

1. Cuff, blood pressure, single use

Product Type

Single Device Product

Effective date

3/02/2014

GMDN

37326 Cuff, blood pressure, single use

Intended purpose

A bandlike device encircling a body part.

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 06:32:36 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