BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Heart-Valve, Mechanical

    PMA: P990046 · Supplement: S006 · Decision May 29, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Heart-Valve, Mechanical
    Trade Name
    ATS OPEN PIVOT BILEAFLET
    PMA Number
    P990046
    Supplement Number
    S006
    Device Class
    FDA Class 3
    Product Code
    LWQ
    Generic Name
    HEART-VALVE, MECHANICAL
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 29, 2002
    Date Received
    May 1, 2002
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Express GMP Supplement
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO TRANSFER THE MANUFACTURING OF THE PYROLYTIC CARBON COATED HEART VALVE COMPONENTS FROM SULZER CARBOMEDICS, INC., TO ATS MEDICAL INC., MINNEAPOLIS, MINNESOTA.

    Classifications

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

    Product Code Device Name
    LWQ Heart-Valve, Mechanical