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
Level 1 407 Pacific Highway,ARTARMON, NSW, 2064
ARTG Start Date
Medical Device Class 1
- 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
ARTARMON, NSW, 2064
1. Saluda Medical MCS - Stimulator, electrical, analgesic, spinal cord
Medical device system
36007 Stimulator, electrical, analgesic, spinal cord
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.
No Specific Conditions included on Record
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