Catheter balloon inflation system, single-use
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
08-11-2019
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Available from:
Edwards Lifesciences Pty Ltd
Class:
Class Is
Manufactured by:
Edwards Lifesciences LLC One Edwards Way, Irvine, California, 92614 United States Of America
Therapeutic area:
17541 - Catheter balloon inflation system, single-use
Therapeutic indications:
The Edwards Inflation Device is indicated for use in performing EDWARDS INTUITY Elite balloon dilation procedures to inflate the balloon, monitor the pressure within the balloon and deflate the balloon.
Authorization status:
A
Authorization date:
2019-09-16
