AlCath

Main information

  • Trade name:
  • AlCath Flutter Flux Black G eXtra - Catheter, cardiac, ablation
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • AlCath Flutter Flux Black G eXtra - Catheter, cardiac, ablation
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221411
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221411

Biotronik Australia Pty Ltd - AlCath Flutter Flux Black G eXtra - Catheter, cardiac, ablation

ARTG entry for

Medical Device Included Class III

Sponsor

Biotronik Australia Pty Ltd

Postal Address

Suite 2 Level 4 Building 2,20 Bridge Street,PYMBLE, NSW, 2073

Australia

ARTG Start Date

18/03/2014

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

Vascomed GmbH

Hertzallee 1

, Binzen, D-79589

Germany

Products

1. AlCath Flutter Flux Black G eXtra - Catheter, cardiac, ablation

Product Type

Single Device Product

Effective date

18/03/2014

GMDN

35855 Catheter, cardiac, ablation

Functional description

Temporary unidirectional steerable quadripolar irrigated catheters for sensing of intracardiac signals and

RF ablation of cardiac tachyarrhythmia. A thermocouple monitors/controls temperature during RF current

ablation. Gold electrodes minimise transition resistances, maximising conductance. A deflectable tip has

increased lateral stability, is softer & more flexible than in the transverse direction. Ablations in the

cavo-tricuspid isthmus in the right atrium & treating atrial flutter.

Intended purpose

The catheters of the AlCath® family are temporary unidirectional steerable quadripolar catheters for

intracardiac RF ablation as well as for sensing of intracardiac signals. They are intended for treatment of

supraventricular/ventricular cardiac tachyarrhythmia or AV node reentry tachycardia.

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 23.11.2017 at 08:18:12 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