Epic Valve Mitral Model E100 - Mitral heart valve bioprosthesis
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Public Assessment Report
(PAR)
15-11-2017
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Available from:
Abbott Medical Australia Pty Ltd
Class:
Class III
Manufactured by:
St Jude Medical 177 East County Road B, St Paul, MN, 55117 United States Of America
Therapeutic area:
60244 - Mitral heart valve bioprosthesis
Therapeutic indications:
The SJM Epic Mitral Valve is a triple-composite bioprosthetic heart valve manufactured from select porcine aortic valve cusps. The SJM Epic Mitral Valve is intended as a replacement for a diseased, damaged or malformed mitral native heart valve. It may also be used as a replacement for a previously implanted mitral prosthetic heart valve.
Authorization status:
A
Authorization date:
2009-09-03
