Summary for ARTG Entry:
Medistar 2 Pty Ltd as Trustee for the JVOT Family Trust T/a Medistar - Surgical procedure kit,
general-purpose, single-use, non-medicated
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. Surgical procedure kit, general-purpose, single-use, non-medicated
33961 Surgical procedure kit, general-purpose, single-use, non-medicated
A procedure pack consisting of a temporary stimulation lead and additional components required for its
insertion. Once inserted the lead is connected to the separately supplied SMARTPATCH PNS, which is a
peripheral nerve stimulator indicated for the symptomatic relief and management of chronic shoulder pain
for up to 30 days.
No Specific Conditions included on Record
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Produced at 02.12.2017 at 04:55:21 AEDT
This is not an ARTG Certificate document.
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