Stimulator, electrical, analgesic, spinal cord

Australia - English - Department of Health (Therapeutic Goods Administration)

Buy It Now

Available from:
Saluda Medical Pty Ltd
Class:
Class 1
Authorization status:
Included (Export Only)
Authorization number:
321465

Public Summary

Summary for ARTG Entry:

321465

Saluda Medical Pty Ltd - Stimulator, electrical, analgesic, spinal cord

ARTG entry for

Medical Device Included (Export Only) Class 1

Sponsor

Saluda Medical Pty Ltd

Postal Address

Level 1 407 Pacific Highway,ARTARMON, NSW, 2064

Australia

ARTG Start Date

8/08/2019

Product category

Medical Device Class 1

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

Saluda Medical Pty Ltd

Level 1 407 Pacific Highway

ARTARMON, NSW, 2064

Australia

Products

1. Stimulator, electrical, analgesic, spinal cord

Product Type

Single Device Product

Effective date

8/08/2019

GMDN

36007 Stimulator, electrical, analgesic, spinal cord

Intended purpose

The Evoke Intraoperative Cable Kit allows the external stimulator to be connected to the implanted leads

for intraoperative testing.

Specific Conditions

© 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 02.11.2019 at 07:36:51 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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