BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Heart-Valve, Non-Allograft Tissue

    PMA: P130011 · Decision Jun 24, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19

    Basic Information

    Device Name
    Heart-Valve, Non-Allograft Tissue
    Trade Name
    FREEDOM SOLO STENTLESS HEART VALVE
    PMA Number
    P130011
    Device Class
    FDA Class 3
    Product Code
    LWR
    Generic Name
    heart-valve, non-allograft tissue
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    June 24, 2014
    Date Received
    May 13, 2013
    Expedited Review
    N
    Docket Number
    14M-1064

    Advisory Committee Statement

    APPROVAL FOR THE FREEDOM SOLO STENTLESS HEART VALVE AND SOLO SMART STENTLESS HEART VALVE. THESE DEVICES ARE INDICATED FOR THE REPLACEMENT OF DISEASED, DAMAGED, OR MALFUNCTIONING NATIVE OR PROSTHETICAORTIC VALVES.

    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