Clinician

Main information

  • Trade name:
  • Clinician Programmer NM-7153-30 - Computer, laptop
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Clinician Programmer NM-7153-30 - Computer, laptop
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 217296
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

217296

Boston Scientific Pty Ltd - Clinician Programmer NM-7153-30 - Computer, laptop

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

14/11/2013

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. Clinician Programmer NM-7153-30 - Computer, laptop

Product Type

Single Device Product

Effective date

14/11/2013

GMDN

38453 Computer, laptop

Functional description

Clinician Programmer allows the set-up and adjustment of stimulation parameters for the Precision &

Precision Spectra Spinal Cord Stimulator System via a Programming Wand. The Programming Wand uses

radio frequency link to communicate with the stimulator.

Intended purpose

The Clinician Programmer (CP) uses software that allows the set-up and adjustment of stimulation

parameters for the Stimulator (implantable pulse generator or external trial stimulator).

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 02:41:32 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