- Implantable electrical stimulation device management software

Main information

  • Trade name:
  • - Implantable electrical stimulation device management software
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • - Implantable electrical stimulation device management software
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Included
  • Authorization number:
  • 322574
  • Last update:
  • 06-10-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

322574

Saluda Medical Pty Ltd - Implantable electrical stimulation device management software

ARTG entry for

Medical Device Included Class 1

Sponsor

Saluda Medical Pty Ltd

Postal Address

Level 1 407 Pacific Highway,ARTARMON, NSW, 2064

Australia

ARTG Start Date

2/09/2019

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

Saluda Medical Pty Ltd

Level 1 407 Pacific Highway

ARTARMON, NSW, 2064

Australia

Products

1. - Implantable electrical stimulation device management software

Product Type

Single Device Product

Effective date

2/09/2019

GMDN

60363 Implantable electrical stimulation device management software

Intended purpose

The Evoke Clinical Data Viewer is a software application used to display and analyse data generated by

the spinal cord stimulator and programming software.

Specific Conditions

© 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 02.11.2019 at 05:27:03 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