General/multiple surgical laser system beam guide, single-use

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

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Available from:
Boston Scientific Pty Ltd
Class:
Class IIa
Authorization status:
Included
Authorization number:
293036

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Public Summary

Summary for ARTG Entry:

293036

Boston Scientific Pty Ltd - General/multiple surgical laser system beam guide, single-use

ARTG entry for

Medical Device Included Class IIa

Sponsor

Boston Scientific Pty Ltd

Postal Address

PO Box 332,BOTANY, NSW, 1455

Australia

ARTG Start Date

21/08/2017

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

Boston Scientific Corporation

300 Boston Scientific Way

Marlborough, MA, 01752

United States Of America

Products

1. General/multiple surgical laser system beam guide, single-use

Product Type

Single Device Product

Effective date

21/08/2017

GMDN

62600 General/multiple surgical laser system beam guide, single-use

Intended purpose

The single-use laser fibers are compatible with surgical laser systems for indications that are cleared for

these laser system. This may include but is not limited to surgical procedures involving endoscopic,

laparoscopic and open surgical procedures involving vaporization, ablation, fragmentation of calculi

(urinary and biliary), coagulation, hemostasis, excision, resection and incision of soft and cartilaginous

tissues.

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 03.11.2017 at 06:09:04 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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