Saluda

Main information

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

Documents

Localization

  • Available in:
  • Saluda Medical MCS - Stimulator, electrical, analgesic, spinal cord
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222507
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222507

Saluda Medical Pty Ltd - Saluda Medical MCS - 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

Saluda Medical Pty Ltd

Level 1 407 Pacific Highway

ARTARMON, NSW, 2064

Australia

Products

1. Saluda Medical MCS - 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 a first

in human non-significant risk clinical study in the USA evaluating the incorporated feedback control using

Evoked Compound Action Potentials (ECAP) to aid in the accurate positioning of paddle Spinal Cord

Stimulation (SCS) leads. ). The device attaches to the paddle lead (not part of our device or system) being

implanted in the epidural spaces of the spinal cord into which signals and/or energy is inductively coupled

from outside the body and the ECAP measures are recorded and used to position the lead. Once

implanted the lead is then coupled with an analgesic spinal cord stimulators 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 09:18:27 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