Summary for ARTG Entry:
Johnson & Johnson Medical Pty Ltd - Webster Fixed Curve Electrophysiology Catheter with Auto ID -
Catheter, cardiac, electrophysiological mapping
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. Webster Fixed Curve Electrophysiology Catheter with Auto ID - Catheter, cardiac, electrophysiological
Single Device Product
44867 Catheter, cardiac, electrophysiological mapping
Electrophysiology catheters incorporating a high-torque shaft which assists in positioning the catheter tip at
the desired site. The distal tip contains an array of platinum electrodes that can be used for recording and
The catheter is indicated for electrophysiological mapping of cardiac structures; i.e., stimulation and
EP Catheter number of electrodes 4 and 8
Electrode spacing on lead/catheter 2mm and 5 mm
No Specific Conditions included on Record
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Produced at 10.11.2017 at 08:05:54 AEDT
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