Summary for ARTG Entry:
Medistar 2 Pty Ltd as Trustee for the JVOT Family Trust T/a Medistar - Stimulator, electrical, analgesic,
peripheral nerve, implantable
ARTG entry for
Medical Device Included Class IIa
Medistar 2 Pty Ltd as Trustee for the JVOT Family Trust T/a Medistar
Level 3 / 349 Coronation Drive,Milton, QLD, 4064
ARTG Start Date
Medical Device Class IIa
- 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.
NDI Medical LLC
22901 Millcreek Boulevard Suite 110
Cleveland, OH, 44122
United States Of America
1. Stimulator, electrical, analgesic, peripheral nerve, implantable
Medical device system
38474 Stimulator, electrical, analgesic, peripheral nerve, implantable
A peripheral nerve stimulator indicated for the symptomatic relief and management of chronic shoulder
pain for up to 30 days. The system includes the SMARTPATCH Stimulator and all the required non-sterile
accessories such as pads, cables, connector tapes, and storage bag. The system is used with a sterile
implanted temporary stimulation lead, which is supplied separately, along with the sterile accessories
required for the implantation of the stimulation lead.
No Specific Conditions included on Record
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Produced at 02.12.2017 at 04:55:36 AEDT
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