EV1000

Main information

  • Trade name:
  • EV1000 Clinical Platform NI - Patient monitoring system module, blood pressure, noninvasive
  • Class:
  • Class IIb
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • EV1000 Clinical Platform NI - Patient monitoring system module, blood pressure, noninvasive
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220227
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220227

Edwards Lifesciences Pty Ltd - EV1000 Clinical Platform NI - Patient monitoring system module, blood

pressure, noninvasive

ARTG entry for

Medical Device Included Class IIb

Sponsor

Edwards Lifesciences Pty Ltd

Postal Address

PO Box 137,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

18/02/2014

Product category

Medical Device Class IIb

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. EV1000 Clinical Platform NI - Patient monitoring system module, blood pressure, noninvasive

Product Type

Medical device system

Effective date

18/02/2014

GMDN

36551 Patient monitoring system module, blood pressure, noninvasive

Intended purpose

A monitor that noninvasively measures blood presure and associated haemodynamic parameters,

including cardiac output, mean arterial pressure and stroke volume in patients with co-morbidities for which

haemodynamic optimization is desired and invasive measurement is difficult.

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 04:51:35 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