BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Heart-Valve, Mechanical

    PMA: P900060 · Supplement: S007 · Decision Oct 26, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Heart-Valve, Mechanical
    Trade Name
    CARBOMEDICS(R) PROSTHETIC HEART VALVE (CPHV)
    PMA Number
    P900060
    Supplement Number
    S007
    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
    October 26, 1995
    Date Received
    December 20, 1994
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO ADD AN ADDITIONAL STERILIZATION PROTOCOL TO THE CPHV INSTRUMENTATION INSTRUCTIONS FOR USE

    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