Australia - English - Department of Health (Therapeutic Goods Administration)

saluda medical pty ltd - 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.

Australia - English - Department of Health (Therapeutic Goods Administration)

saluda medical pty ltd - 47487 - medical device electrical cable, general purpose - a sterile adapter cable to allow the external trial stimulator to be connected to the implanted leads or lead extensions for intraoperative testing and trial stimulation.

Australia - English - Department of Health (Therapeutic Goods Administration)

saluda medical pty ltd - 37685 - bag, medical device, reusable - the evoke accessory belt is an aid in securing and maintaining external components of the evoke system near the patient?s implant site.

Australia - English - Department of Health (Therapeutic Goods Administration)

saluda medical pty ltd - 60363 - implantable electrical stimulation device management software - the evoke clinical data viewer is a software application used to analyse data generated by the evoke spinal cord stimulation system.

Australia - English - Department of Health (Therapeutic Goods Administration)

saluda medical pty ltd - 60363 - implantable electrical stimulation device management software - the evoke clinical programming application is used by clinical staff to program the spinal cord stimulator.

Australia - English - Department of Health (Therapeutic Goods Administration)

saluda medical pty ltd - 60363 - implantable electrical stimulation device management software - the evoke firmware upgrade application is a software application which allows upgrade of the spinal cord stimulator with new firmware.

Australia - English - Department of Health (Therapeutic Goods Administration)

saluda medical pty ltd - 17115 - battery charger - the evoke charger is used to inductively charge the implantable/external spinal cord stimulator. it consists of a charger coil and a charging unit. the evoke charger is rechargeable, and is supplied with a power adapter.

Australia - English - Department of Health (Therapeutic Goods Administration)

saluda medical pty ltd - 36007 - stimulator, electrical, analgesic, spinal cord - the evoke tunneling tool allows the subcutaneous threading of leads and/or lead extensions, either to an exit incision for the trial stimulation period, or to the implanted stimulator.

Australia - English - Department of Health (Therapeutic Goods Administration)

saluda medical pty ltd - 36007 - stimulator, electrical, analgesic, spinal cord - the evoke lead adapter kit allows the external stimulator to be connected to the implanted leads for intraoperative testing and trial stimulation.

Australia - English - Department of Health (Therapeutic Goods Administration)

saluda medical pty ltd - 36007 - stimulator, electrical, analgesic, spinal cord - the evoke spares kit contains spare lead anchors and surgical accessories for the surgical placement of leads and/or an implanted stimulator.