Stimulator

Main information

  • Trade name:
  • Stimulator, nerve, facial
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Stimulator, nerve, facial
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221732
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221732

Emergo Asia Pacific Pty Ltd T/a Emergo Australia - Stimulator, nerve, facial

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

26/03/2014

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

NeuroSigma Inc

10960 Wilshire Boulevard Suite 1230

Los Angeles, CA, 90024

United States Of America

Products

1. Stimulator, nerve, facial

Product Type

Medical device system

Effective date

26/03/2014

GMDN

35724 Stimulator, nerve, facial

Intended purpose

The Monarch™ eTNS™ System is indicated as adjunctive treatment for patients nine and older with

drug-resistant epilepsy (DRE), defined as failure to achieve seizure freedom following adequate trials of

two or more tolerated and appropriately chosen anti-epileptic drugs, used alone or in combination

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 04:19:11 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