Summary for ARTG Entry:
Boston Scientific Pty Ltd - DYNOGEN ICD VR ± Model D020 - Defibrillator, implantable, automatic
ARTG entry for
Medical Device Included AIMD
Boston Scientific Pty Ltd
PO Box 332,BOTANY, NSW, 1455
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.
Boston Scientific Corporation
4100 Hamline Avenue North
Saint Paul, MN, 55112
United States Of America
1. DYNAGEN ICD VR ± Model D020 - Defibrillator, implantable, automatic
Medical device system
35852 Defibrillator, implantable, automatic
DYNOGEN VRÐsingle-chamber ICD provides combining ventricular tachyarrhythmia therapy with
ventricular pacing and sensing. Cardioversion/defibrillation therapies include a range of low- and
high-energy shocks using a biphasic waveform and choice of multiple shock vectors.
Boston Scientific implantable cardioverter defibrillators (ICDs) are intended to provide ventricular
antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening
Nil variant (as 1 device) N/A
No Specific Conditions included on Record
© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior
written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.
Page 1 of
Produced at 10.11.2017 at 12:25:17 AEDT
This is not an ARTG Certificate document.
The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.
Visit www.tga.gov.au for contact information