Decanav

Main information

  • Trade name:
  • Decanav Electrophysiology Catheter - Catheter, cardiac, electrophysiological mapping
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Decanav Electrophysiology Catheter - Catheter, cardiac, electrophysiological mapping
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217338
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217338

Johnson & Johnson Medical Pty Ltd - Decanav Electrophysiology 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

15/11/2013

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. Decanav Electrophysiology Catheter - Catheter, cardiac, electrophysiological mapping

Product Type

Single Device Product

Effective date

15/11/2013

GMDN

44867 Catheter, cardiac, electrophysiological mapping

Functional description

Used with a cardiac mapping system to reference multiple catheters tip locations in the heart. Has a high

torque shaft with a deflectable tip section containing an array of electrodes that can be used for stimulation

and recording of cardiac electrical signals. Has a single proximal electrode that can be used for unipolar

recording signals. The tip deflection is controlled by a proximal hand piece that features a thumb operated

sliding piston.

Intended purpose

The Decanav catheter is indicated for electrophysiological mapping of cardiac structure i.e., recording and

stimulation, including in the Coronary Sinus. In addition the Decanav catheter is used with compatible

CARTO 3 EP Navigation systems to provide catheter tip location information.

Variant information

Shape (of tip) F - Curve

Shape (of tip) D - Curve

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 02:36:30 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