Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Boston Scientific Pty Ltd - General/multiple surgical laser system beam guide, single-use
ARTG entry for
Medical Device Included Class IIa
Boston Scientific Pty Ltd
PO Box 332,BOTANY, NSW, 1455
ARTG Start Date
Medical Device Class IIa
- 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.
Boston Scientific Corporation
300 Boston Scientific Way
Marlborough, MA, 01752
United States Of America
1. General/multiple surgical laser system beam guide, single-use
Single Device Product
62600 General/multiple surgical laser system beam guide, single-use
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
No Specific Conditions included on Record
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Produced at 03.11.2017 at 06:09:04 AEDT
This is not an ARTG Certificate document.
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