Vectris

Main information

  • Trade name:
  • Vectris 1x8 Compact Trial Screening Lead Kit 977D260 - Electrode/lead, stimulator, implantable, neurological
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Vectris 1x8 Compact Trial Screening Lead Kit 977D260 - Electrode/lead, stimulator, implantable, neurological
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 219259
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

219259

Medtronic Australasia Pty Ltd - Vectris 1x8 Compact Trial Screening Lead Kit 977D260 - Electrode/lead,

stimulator, implantable, neurological

ARTG entry for

Medical Device Included Class III

Sponsor

Medtronic Australasia Pty Ltd

Postal Address

PO Box 945,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

15/01/2014

Product category

Medical Device Class III

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

Medtronic Inc

710 Medtronic Parkway

Minneapolis, MN, 55432

United States Of America

Products

1. Vectris 1x8 Compact Trial Screening Lead Kit 977D260 - Electrode/lead, stimulator, implantable,

neurological

Product Type

Procedure Pack

Effective date

15/01/2014

GMDN

44040 Neural-tissue electrical stimulation lead

Functional description

The lead has electrodes on the distal end; the proximal (connector) end fits into an 8-conductor connection

of an external neurostimulator. The kit contains 1 lead, Guide wire, A curved and straight epidural needle,

bent and straight stylets.

Intended purpose

The Medtronic Vectris 1x8 Compact Model 977D260 Trial Screening Lead is part of a neurostimulation

system for pain therapy.

Variant information

Nil variant (as 1 device) N/A

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 08:04:30 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