Celsius

Main information

  • Trade name:
  • Celsius Flutter Bi-Directional Catheter - Catheter, cardiac, electrophysiological mapping
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Celsius Flutter Bi-Directional Catheter - Catheter, cardiac, electrophysiological mapping
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219379
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219379

Johnson & Johnson Medical Pty Ltd - Celsius Flutter Bi-Directional Catheter - 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

20/01/2014

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. Celsius Flutter Bi-Directional Catheter - Catheter, cardiac, electrophysiological mapping

Product Type

Single Device Product

Effective date

20/01/2014

GMDN

44867 Catheter, cardiac, electrophysiological mapping

Functional description

This is a steerable, multi-electrode catheter with a deflectable tip, and a usable length of 115 cm. The

deflectable tip has one 8 mm platinum/iridium tip electrode and three platinum/iridium ring electrodes used

for pacing and recording ECG signals. The catheters are used in conjunction with a Radiofrequency (RF)

Generator, compatible interface cables, and a grounding (dispersive) pad.

Intended purpose

Indicated for cardiac electrophysiological mapping (stimulation and recording) and, when used in

conjunction with a radiofrequency generator, for cardiac ablation.

Variant information

Nil variant (as 1 device) Nil

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 07:46:34 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