Summary for ARTG Entry:
Boston Scientific Pty Ltd - RELIANCE 4-FRONT dual coil passive fixation - Lead, defibrillator/pacemaker,
ARTG entry for
Medical Device Included Class III
Boston Scientific Pty Ltd
PO Box 332,BOTANY, NSW, 1455
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.
Cardiac Pacemakers Incorporated (A wholly
owned subsidiary of Guidant Corporation A
wholly owned subsidiary of Boston Scientific
4100 Hamline Avenue
St Paul, Minnesota, 55112-5798
United States Of America
1. RELIANCE 4-FRONT dual coil passive fixation - Lead, defibrillator/pacemaker, implantable
Single Device Product
36241 Lead, defibrillator/pacemaker, implantable
RELIANCE 4-FRONT dual coil passive fixation are steroid eluting, endocardial cardioversion/defibrillation
and pace/sense lead that are intended for implantation as an integral part of an (ICD) or (CRT-D) system.
The lead conducts sensed intrinsic cardiac electrical signals from the heart to an implanted device and
delivers, as necessary, electrical pacing or cardioversion/defibrillation (shock) therapy from implanted
device to the heart.
Intended for pacing, rate-sensing, and delivery of cardioversion and debrillation shocks when used with a
compatible pulse generator.
Model number (see guidance docs) 0665
Model number (see guidance docs) 0636
Length (cm) 59
Length (cm) 64
No Specific Conditions included on Record
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