Summary for ARTG Entry:
LivaNova Australia Pty Ltd - Smartview Monitor GPRS - Pacemaker programmer
ARTG entry for
Medical Device Included Class III
LivaNova Australia Pty Ltd
16 - 18 Hydrive Close,South Dandenong, VIC, 3175
ARTG Start Date
Medical Device Class III
- 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.
Sorin Group Italia SRL
Via Crescentino sn 13040 Saluggia VC
1. Smartview Monitor GPRS - Pacemaker programmer
Single Device Product
15993 Pacemaker programmer
The Smartview GPRS model KA971 is a radio frequency wireless monitor that collects clinical information
and and device parameters. The data is retrieved by the portable external monitor from the cardiac device
and is routed through the cellular network, converted to a format that can be reported to the physician
The Smartview GPRS monitor is designed for use with the Sorin radio frequency implanted cardiac
defibrillator specifically to transmit information stored in the implanted cardiac device to the physician.
Nil variant (as 1 device) 0
No Specific Conditions included on Record
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Produced at 10.11.2017 at 01:07:06 AEDT
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