CoverEdge

Main information

  • Trade name:
  • CoverEdge 4x8 Surgical Lead - Electrode/lead, stimulator, implantable, neurological
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • CoverEdge 4x8 Surgical Lead - Electrode/lead, stimulator, implantable, neurological
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218230
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218230

Boston Scientific Pty Ltd - CoverEdge 4x8 Surgical Lead - Electrode/lead, stimulator, implantable,

neurological

ARTG entry for

Medical Device Included Class III

Sponsor

Boston Scientific Pty Ltd

Postal Address

PO Box 332,BOTANY, NSW, 1455

Australia

ARTG Start Date

6/12/2013

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

Boston Scientific Neuromodulation Corporation

25155 Rye Canyon Loop

Valencia, CA, 91355

United States Of America

Products

1. CoverEdge 4x8 Surgical Lead - Electrode/lead, stimulator, implantable, neurological

Product Type

Single Device Product

Effective date

6/12/2013

GMDN

44040 Neural-tissue electrical stimulation lead

Functional description

The distal end of the lead has 4 columns of 8 electrodes. On the proximal side, the lead has 4 tails. The

end of each tail has 8 evenly spaced contacts. Each tail of the paddle lead is identified with marker bands.

Each tail corresponds to the respective column of contacts on the paddle. Each tail can be inserted into an

IPG to deliver electrical stimulation to the nerve structures in the dorsal aspect of the spinal cord resulting

in an inhibition of pain sensation.

Intended purpose

The surgical paddle leads function as a component of the Precision Spectra™ Spinal Cord Stimulation

systems by delivering electrical stimulation to the nerve structures in the dorsal aspect of the spinal cord,

resulting in an inhibition of pain sensation. The 4x8 Surgical Lead is intended for use with the Precision

Spectra System only.

Variant information

Width (mm) 9mm and 10mm

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 11:20:46 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