BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Heart-Valve, Non-Allograft Tissue

    PMA: P790007 · Supplement: S013 · Decision Dec 10, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19

    Basic Information

    Device Name
    Heart-Valve, Non-Allograft Tissue
    Trade Name
    HANCOCK MODIFIED ORIFICE II AORTIC BIOPROSTHESIS
    PMA Number
    P790007
    Supplement Number
    S013
    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
    December 10, 1996
    Date Received
    May 13, 1996
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR TWO ADD'L STYLES (TYPE F AND TYPE G) OF THE MODEL 250 VALVE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES HANCOCK(R) MODIFIED ORIFICE II AORTIC BIOPROSTHESIS, MODEL 250, EXTENDED SUPRA-ANNULAR FLANGE (TYPE F) AND HANCOCK(R) MODIFIED ORIFICE II AORTIC BIOPROSTHESIS, MODEL 250, SUPRA-ANNULAR FLANGE (TYPE G). THE INDICATION FOR USE AND AVAILABLE SIZES (19, 21, 23, AND 25 MM) FOR THE MDOEL 250 VALVES HAVE NOT CHANGED.

    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