Summary for ARTG Entry:
Boston Scientific Pty Ltd - DYNAGEN CRT-D Model G156 - 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 CRT-D Model G156 - Defibrillator, implantable, automatic
Medical device system
35852 Defibrillator, implantable, automatic
CRT-Ds provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of
life-threatening ventricular arrhythmias through a range of low- and high-energy shocks using a biphasic
waveform and choice of multiple shock vectors.
Boston Scientific Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for patients
with heart failure who receive stable optimal pharmacologic therapy (OPT) for heart failure and who meet
any one of the following classifications:
· Moderate to severe heart failure (NYHA Class III-IV) with EF ? 35% and QRS duration ? 120 ms
· Left bundle branch block (LBBB) with QRS duration ? 130 ms, EF ? 30%, and mild (NYHA Class II)
ischemic or nonischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure
Boston Scientific CRT-Ds are also intended to provide ventricular antitachycardia pacing and ventricular
defibrillation for automated treatment of life-threatening ventricular arrhythmias.
Nil variant (as 1 device) N/A
No Specific Conditions included on Record
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