General/multiple surgical laser system beam guide, single-use
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
02-11-2017
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Available from:
Boston Scientific Pty Ltd
Class:
Class IIa
Manufactured by:
Boston Scientific Corporation 300 Boston Scientific Way, Marlborough, MA, 01752 United States Of America
Therapeutic area:
62600 - General/multiple surgical laser system beam guide, single-use
Therapeutic indications:
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.
Authorization status:
A
Authorization date:
2017-08-21
