Webster

Main information

  • Trade name:
  • Webster Fixed Curve Electrophysiology Catheter with Auto ID - Catheter, cardiac, electrophysiological mapping
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Webster Fixed Curve Electrophysiology Catheter with Auto ID - Catheter, cardiac, electrophysiological mapping
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219254
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219254

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

Sponsor

Johnson & Johnson Medical Pty Ltd

Postal Address

PO Box 134,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

15/01/2014

Product category

Medical Device Class III

Status

Active

Approval area

Medical Devices

Conditions

- 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.

Manufacturers

Name

Address

Biosense Webster Inc

33 Technology Drive

Irvine, California, 92618

United States Of America

Products

1. Webster Fixed Curve Electrophysiology Catheter with Auto ID - Catheter, cardiac, electrophysiological

mapping

Product Type

Single Device Product

Effective date

15/01/2014

GMDN

44867 Catheter, cardiac, electrophysiological mapping

Functional description

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

stimulation.

Intended purpose

The catheter is indicated for electrophysiological mapping of cardiac structures; i.e., stimulation and

recording only.

Variant information

EP Catheter number of electrodes 4 and 8

Electrode spacing on lead/catheter 2mm and 5 mm

Specific Conditions

No Specific Conditions included on Record

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 10.11.2017 at 08:05:54 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information