EDWARDS INTUITY Elite Valve System - Aortic heart valve bioprosthesis

国: オーストラリア

言語: 英語

ソース: Department of Health (Therapeutic Goods Administration)

即購入

公開評価報告書 公開評価報告書 (PAR)
06-11-2017

から入手可能:

Edwards Lifesciences Pty Ltd

クラス:

Class III

製:

Edwards Lifesciences LLC One Edwards Way, Irvine, California, 92614 United States Of America

治療領域:

60242 - Aortic heart valve bioprosthesis

適応症:

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.

認証ステータス:

A

承認日:

2015-10-22

この製品に関連するアラートを検索