COBRA

Main information

  • Trade name:
  • COBRA Fusion Ablation System - Electrosurgical system, general-purpose
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • COBRA Fusion Ablation System - Electrosurgical system, general-purpose
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219051
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219051

Pacing Importers Pty Ltd - COBRA Fusion Ablation System - Electrosurgical system, general-purpose

ARTG entry for

Medical Device Included Class III

Sponsor

Pacing Importers Pty Ltd

Postal Address

8-12 Alma Road,ST KILDA, VIC, 3182

Australia

ARTG Start Date

9/01/2014

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

Endoscopic Technologies Inc dba Estech

Suite 100 / 2603 Camino Ramon

San Ramon, CA, 94583

United States Of America

Products

1. COBRA Fusion Ablation System - Electrosurgical system, general-purpose

Product Type

Medical device system

Effective date

9/01/2014

GMDN

44776 Electrosurgical system, general-purpose

Functional description

The system comprises a flexible ablation catheter, designed to conform to specific anatomy of tissue to be

ablated with integrated suction stabilizer to engage tissue under vacuum for constant catheter

electrode/tissue contact. Magnetically coupled, the introducer is used to advance the catheter to desired

anatomical position. The catheter allows any combination of electrodes to be activated. Connected to the

ESU, RF energy is directed from active electrodes in selected Bipolar/Monopolar mode.

Intended purpose

The ESTECH Cobra Fusion Ablation System is intended to ablate cardiac tissue during cardiac surgery

using radiofrequency (RF) energy when connected directly to the Estech Electrosurgical unit (ESU)

Variant information

Length (mm) 50 and 150

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 08:33:56 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

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