BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Heart-Valve, Non-Allograft Tissue

    PMA: P100029 · Decision Apr 20, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19

    Basic Information

    Device Name
    Heart-Valve, Non-Allograft Tissue
    Trade Name
    ST JUDE MEDICAL TRIFECTA VALVE
    PMA Number
    P100029
    Device Class
    FDA Class 3
    Product Code
    LWR
    Generic Name
    heart-valve, non-allograft tissue
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 20, 2011
    Date Received
    July 20, 2010
    Expedited Review
    N
    Docket Number
    11M-0296

    Advisory Committee Statement

    APPROVAL FOR THE ST. JUDE MEDICAL TRIFECTA VALVE. THE TRIFECTA VALVE IS INTENDED AS A REPLACEMENT FOR A DISEASED, DAMAGED, OR MALFUNCTIONING NATIVE OR PROSTHETIC AORTIC HEART VALVE.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LWR Heart-Valve, Non-Allograft Tissue