Varicose

Main information

  • Trade name:
  • Varicose vein lasing procedure kit
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Varicose vein lasing procedure kit
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217834
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217834

Emergo Asia Pacific Pty Ltd T/a Emergo Australia - Varicose vein lasing procedure kit

ARTG entry for

Medical Device Included Class IIa

Sponsor

Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Postal Address

Level 20 Tower II Darling Park 201 Sussex Street,SYDNEY, NSW, 2000

Australia

ARTG Start Date

28/11/2013

Product category

Medical Device Class IIa

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

AngioDynamics Inc

603 Queensbury Avenue

Queensbury, New York, 12804

United States Of America

Products

1. Varicose vein lasing procedure kit

Product Type

Procedure Pack

Effective date

28/11/2013

GMDN

47535 Varicose vein lasing procedure kit

Intended purpose

The devices are laser fibers in a procedure pack with other accessories indicated for endovascular

coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of

varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and

for the treatment of incompetence and reflux of superficial veins of the lower extremity. This product should

be used only with lasers cleared for the use in treatment of varicose veins, varicosities with superficial

reflux of the GSV, and in the treatment of incompetent refluxing veins in the superficial venous system in

the lower limbs. In addition to the laser fiber, the procedure pack contains an entry needle, guidewire, and

introducer sheath.

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 02.12.2017 at 04:51:35 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