Main information

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



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

Other information


  • 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:


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

ARTG entry for

Medical Device Included (Export Only) Class 1


Saluda Medical Pty Ltd

Postal Address

Level 1 407 Pacific Highway,ARTARMON, NSW, 2064


ARTG Start Date


Product category

Medical Device Class 1



Approval area

Medical Devices


- 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.




Saluda Medical Pty Ltd

Level 1 407 Pacific Highway




1. Saluda Medical MCS - Stimulator, electrical, analgesic, spinal cord

Product Type

Medical device system

Effective date



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

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written approval from the Commonwealth.Further details can be found at

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.

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