Summary for ARTG Entry:
LivaNova Australia Pty Ltd - VNS Therapy Aspire HC Pulse Generator Model 105 - Stimulator, electrical,
vagus nerve, antiseizure
ARTG entry for
Medical Device Included AIMD
LivaNova Australia Pty Ltd
16 - 18 Hydrive Close,South Dandenong, VIC, 3175
ARTG Start Date
Medical Device AIMD
- 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.
100 Cyberonics Boulevard
Houston, TX, 77058
United States Of America
1. VNS Therapy Aspire HC Pulse Generator Model 105 - Stimulator, electrical, vagus nerve, antiseizure
Single Device Product
34210 Antiseizure/psychiatric-therapy vagus nerve electrical stimulation system
The Pulse Generator is an implantable, multiprogrammable pulse generator that delivers electrical signals
to the vagus nerve. The Pulse Generator is housed in a hermetically sealed titanium case and is powered
by a single battery. Electrical signals are transmitted from the Pulse Generator to the vagus nerve by the
Lead. The Lead and the Pulse Generator make up the implantable portion of the VNS Therapy System.
The Vagus Nerve Stimulation Therapy System is indicated for the treatment of chronic or recurrent
depression in patients that are in a
treatment-resistant or treatment-intolerant major depressive episode and for use as an adjunctive therapy
in reducing the frequency of
seizures in patients whose epileptic disorder is dominated by partial seizures or generalized seizures that
are refractory to antiepileptic
Nil variant (as 1 device) 0
No Specific Conditions included on Record
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