EDWARDS INTUITY Elite Valve System - Aortic heart valve bioprosthesis
Land: Australia
Språk: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
Offentlig vurderingsrapport
(PAR)
06-11-2017
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Tilgjengelig fra:
Edwards Lifesciences Pty Ltd
Klasse:
Class III
Produsert av:
Edwards Lifesciences LLC One Edwards Way, Irvine, California, 92614 United States Of America
Terapeutisk område:
60242 - Aortic heart valve bioprosthesis
Indikasjoner:
The EDWARDS INTUITY Elite Valve System is an implantable surgical heart valve bioprosthesis, a delivery system and an inflation device. When used together as intended these system components allow minimally invasive surgical implantation of the EDWARDS INTUITY Elite heart valve into the native aortic annulus. The valve is indicated for patients whose aortic valvular disease is sufficiently advanced to warrant replacement of their native valve with a prosthetic valve.
Autorisasjon status:
A
Autorisasjon dato:
2015-10-22
