Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Halyard Australia Pty Ltd - Supply unit, cooling
ARTG entry for
Medical Device Included Class IIb
Halyard Australia Pty Ltd
PO Box 385,MILSONS POINT, NSW, 1565
ARTG Start Date
Medical Device Class IIb
- 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.
Halyard Health Inc
5405 Windward Parkway
Alpharetta, GA, 30004
United States Of America
1. Supply unit, cooling
Medical device system
37147 Supply unit, cooling
The HALYARD* COOLIEF* Cooled Radiofrequency Peristaltic Pump unit is to be used in conjunction with
a COOLIEF* Cooled RF Generator and with COOLIEF* TRANSDISCAL Cooled Radiofrequency Kit for
coagulation and decompression of the disc material for symptomatic patients with contained herniated
discs. It is also to be used with COOLIEF* SINERGY* cooled radiofrequency Kit and other cooled RF
probes to create RF lesions in nervous tissue including the sacral region.
This device is also indicated for creating radiofrequency lesions of the genicular nerves for the
management of moderate to severe knee pain.
HALYARD* COOLIEF Cooled Radiofrequency Peristaltic Pump Unit is used for closed-loop circulation of
sterile water through the system during the RF lesioning procedures.
No Specific Conditions included on Record
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Produced at 03.11.2017 at 05:26:08 AEDT
This is not an ARTG Certificate document.
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