Summary for ARTG Entry:
Boston Scientific Pty Ltd - RELIANCE 4-FRONT single coil passive fixation w/GORE - Lead,
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 single coil passive fixation w/GORE - Lead, defibrillator/pacemaker, implantable
Single Device Product
36241 Lead, defibrillator/pacemaker, implantable
RELIANCE 4-FRONT single coil passive fixation w/GORE 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) 0654
Model number (see guidance docs) 0683
Model number (see guidance docs) 0682
Length (cm) 70
Length (cm) 64
Length (cm) 59
No Specific Conditions included on Record
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