Summary for ARTG Entry:
Johnson & Johnson Medical Pty Ltd - SoundStar eco Diagnostic Ultrasound Catheter - Transducer
assembly, ultrasound, diagnostic, intracorporeal, intravascular
ARTG entry for
Medical Device Included Class III
Johnson & Johnson Medical Pty Ltd
PO Box 134,NORTH RYDE BC, NSW, 1670
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.
Biosense Webster Inc
33 Technology Drive
Irvine, California, 92618
United States Of America
1. SoundStar eco Diagnostic Ultrasound Catheter - Transducer assembly, ultrasound, diagnostic,
Single Device Product
37895 Transducer assembly, ultrasound, diagnostic, intracorporeal, intravascular
These catheters are advanced into the vasculature through the catheter introducer. The distal end of the
catheter has an ultrasound transducer providing 2D imaging and a 3D location sensor providing location
information to the navigation system.Once inside the heart the catheter is steered using the steering knobs
to direct the ultrasound transducer for visualisation of the target cardiac anatomy.
Indicated for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and
physiology as well as
visualization of other devices in the heart. When used with compatible CARTO® 3 EP Navigation
Systems, the SOUNDSTAR® eco Catheter provides location information.
Model number (see guidance docs) 10F and 10FG
No Specific Conditions included on Record
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