Riik: Austraalia
keel: inglise
Allikas: Department of Health (Therapeutic Goods Administration)
Abbott Medical Australia Pty Ltd
Class III
Abbott Medical 177 County Road B East, St Paul, Minnesota, 55117 United States Of America
60246 - Mitral transcatheter heart valve bioprosthesis
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.
A
2022-12-14