Summary for ARTG Entry:
LivaNova Australia Pty Ltd - Smartview Monitor PSTN - 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 PSTN - Pacemaker programmer
Single Device Product
15993 Pacemaker programmer
The Smartview PSTN (Public Switched Telephone Network) model KA970 is part of the Smartview remote
monitoring system, specifically designed to transmit information stored in the cardiac device to the
physician. The cardiac device is equipped with a transmitter which sends information and device
parameters through the monitor using radio frequency wireless technology. The data retrieved by the
monitor is routed through the phone network, converted to a format that is reported to the physician.
The Smartview PSTN monitor is designed for use with the Sorin radio frequency implanted cardiac device
only and any household traditional (analog type) telephone land line 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 01:07:22 AEDT
This is not an ARTG Certificate document.
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