Electromechanical

Main information

  • Trade name:
  • Electromechanical lithotripsy system, extracorporeal
  • Class:
  • Class IIb
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Electromechanical lithotripsy system, extracorporeal
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221439
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221439

Lithostar Pty Ltd ATF The Mansell Family Trust - Electromechanical lithotripsy system, extracorporeal

ARTG entry for

Medical Device Included Class IIb

Sponsor

Lithostar Pty Ltd ATF The Mansell Family Trust

Postal Address

58 Mintaro Parade,QUINNS ROCKS, WA, 6030

Australia

ARTG Start Date

19/03/2014

Product category

Medical Device Class IIb

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

Dornier MedTech GmbH

Argelsrieder Feld 7

Wessling, , D 82234

Germany

Products

1. Electromechanical lithotripsy system, extracorporeal

Product Type

Single Device Product

Effective date

19/03/2014

GMDN

18415 Electromechanical lithotripsy system, extracorporeal

Intended purpose

The intended purpose of this device is to send non - invasive shock waves from outside the body in order

to fragment or pulverize stones that have developed within the body allowing them to pass from the body

as sand sized fragments during natural excretion

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 01:04:10 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