Catheter, gastrointestinal balloon
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
09-11-2017
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Available from:
Medtronic Australasia Pty Ltd
Class:
Class IIa
Manufactured by:
Covidien llc 15 Hampshire Street, Mansfield, MA, 02048 United States Of America
Therapeutic area:
45712 - Catheter, gastrointestinal balloon
Therapeutic indications:
Indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to Barrett's Esophogusand Esophageal and Squamous Cell Neoplasia, defined as moderate grade intra-epithelial neoplasia, high-grade intraepithelial neoplasia and/or early squamous cell carcinoma of the esophagus limited to the lamina propria.
Authorization status:
A
Authorization date:
2014-01-28
