Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Biotronik Australia Pty Ltd - Evity 8 SR-T - Single-chamber pacemaker, rate-responsive
ARTG entry for
Medical Device Included AIMD
Biotronik Australia Pty Ltd
Suite 2 Level 4 Building 2,20 Bridge Street,PYMBLE, NSW, 2073
ARTG Start Date
Medical Device AIMD
- 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.
Biotronik SE & Co KG
, Berlin, 12359
1. Evity 8 SR-T - Single-chamber pacemaker, rate-responsive
Single Device Product
47267 Single-chamber pacemaker, rate-responsive
Evity 8 SR-T housing is made of biocompatible titanium, welded from the outside and hermetically sealed.
The ellipsoid shape facilitates ingrowth into the pectoral muscle area. The housing serves as an antipole in
the case of unipolar lead configuration. Implantable Cardiac Pulse Generator, single Chamber, Rate
Adaptive, unipolar/bipolar, IS-1 Compatible, with Home Monitoring. ProMRI® labelled (MR conditional)
pacemakers are conditionally safe for use in the MRI environment.
Evity is a family of implantable pacemakers that can be implanted for all bradycardia arrhythmia
indications. The primary objective of the therapy consists of improving patients' symptoms that can be
clinically manifested. The implantation of the pacemaker is a symptomatic therapy with the following
·Compensation of bradycardia by atrial or ventricular pacing
Nil variant (as 1 device) Model number: 407158
No Specific Conditions included on Record
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Produced at 01.12.2017 at 11:42:27 AEDT
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