Nerve-locating

Main information

  • Trade name:
  • Nerve-locating system, line-powered
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Nerve-locating system, line-powered
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218608
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218608

National Surgical Pty Ltd - Nerve-locating system, line-powered

ARTG entry for

Medical Device Included Class IIa

Sponsor

National Surgical Pty Ltd

Postal Address

239 Milton Road,MILTON, QLD, 4064

Australia

ARTG Start Date

17/12/2013

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

Innovative Surgical Solutions LLC

21520 Bridge Street

Southfield, MI, 48033

United States Of America

Products

1. Nerve-locating system, line-powered

Product Type

Medical device system

Effective date

17/12/2013

GMDN

46456 Nerve-locating system, line-powered

Intended purpose

The device consists of a control unit, power supply, sensor harness and user manual packaged together

as a system. The device is intended for use in surgical procedures to assist the surgeon in locating and

mapping motor nerves through the use of mechanomyographic (MMG) signals and electrical stimulus of

nerves. The device is indicated for locating and identifying spinal nerce roots and peripheral motor nerves

originating from spinal nerves C3-T1 and L2-S2.

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 09:54:14 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

30-7-2018

Zalmoxis (MolMed S.p.A.)

Zalmoxis (MolMed S.p.A.)

Zalmoxis (Active substance: Allogeneic T cells genetically modified with a retroviral vector encoding for a truncated form of the human low affinity nerve growth factor receptor (?LNGFR) and the herpes simplex I virus thymidine kinase (HSV-TK Mut2)) - Centralised - Renewal - Commission Decision (2018)5118 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2801/R/10

Europe -DG Health and Food Safety