Tendyne Mitral Valve Delivery System - Mitral transcatheter heart valve bioprosthesis

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Osta kohe

Laadi alla Avaliku hindamisaruande (PAR)
19-07-2023

Saadav alates:

Abbott Medical Australia Pty Ltd

Klass:

Class III

Valmistatud:

Abbott Medical 177 County Road B East, St Paul, Minnesota, 55117 United States Of America

Terapeutiline ala:

60246 - Mitral transcatheter heart valve bioprosthesis

Näidustused:

The Tendyne Mitral Valve Delivery System consists of Tendyne Loading System, Tendyne Delivery System, Tendyne Pad Positioning System, Tendyne Stand Components and non-sterile, reusable Tendyne Loading Stand and Tendyne Weight. The Loading System collapses the Valve into a loading tube. The Delivery System introduces the sheath tip through the ventricular myocardium to the mitral annulus to facilitate deployment of the valve. The Pad Positioning System fastens Apical Pad to the braided tether. The Tendyne Mitral Valve Delivery System is intended for preparation, loading, delivery and securement of the Tendyne Mitral Valve and the Tendyne Apical Pad.

Volitamisolek:

A

Loa andmise kuupäev:

2022-12-14

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