Summary for ARTG Entry:
Saluda Medical Pty Ltd - 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.
4/18 Lexington Drive
BELLA VISTA, NSW, 2153
1. 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 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.
No Specific Conditions included on Record
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Produced at 09.11.2017 at 09:18:42 AEDT
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