Summary for ARTG Entry:
Boston Scientific Pty Ltd - AUTOGEN ICD DR ± Model D047 - 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. AUTOGEN ICD DR ± Model D047 - Defibrillator, implantable, automatic, dual-chamber
Medical device system
37265 Defibrillator, implantable, automatic, dual-chamber
AUTOGEN DRÐdual-chamber ICD combines ventricular tachyarrhythmia therapy with ventricular and
atrial 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
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