Stimulator

Main information

  • Trade name:
  • Stimulator, electrical, analgesic, spinal cord
  • Class:
  • (Export Only) Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Stimulator, electrical, analgesic, spinal cord
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222506
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222506

Saluda Medical Pty Ltd - Stimulator, electrical, analgesic, spinal cord

ARTG entry for

Medical Device Included (Export Only) Class 1

Sponsor

Saluda Medical Pty Ltd

Postal Address

Level 1 407 Pacific Highway,ARTARMON, NSW, 2064

Australia

ARTG Start Date

15/04/2014

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

Circuitwise Electronics

4/18 Lexington Drive

BELLA VISTA, NSW, 2153

Australia

Products

1. Stimulator, electrical, analgesic, spinal cord

Product Type

Medical device system

Effective date

15/04/2014

GMDN

36007 Stimulator, electrical, analgesic, spinal cord

Intended purpose

External Trial Stimulator EXPORT ONLY Stimulator, electrical, analgesic, spinal cord. For use under an

IDE in the USA within a 30 day cross-over trial examining the safety and effectiveness of using spinal cord

stimulation incorporating feedback to treat patients with chronic pain of the trunk and/or limbs. The

stimulator applies stimulus to any part of the spinal cord for the purposes of relieving pain (analgesia). It

attaches to an existing (not part of our device or system) implanted lead/electrode system located in the

epidural spaces of the spinal cord. Analgesic spinal cord stimulators are used to treat acute and/or chronic

intractable pain, where the use of drug therapy is undesirable or no longer effective.

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 09.11.2017 at 09:18:42 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