BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Heart-Valve, Mechanical

    PMA: P900060 · Supplement: S022 · Decision Feb 16, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Heart-Valve, Mechanical
    Trade Name
    CARBOMEDICS PROSTHETIC HEART VALVE
    PMA Number
    P900060
    Supplement Number
    S022
    Device Class
    FDA Class 3
    Product Code
    LWQ
    Generic Name
    HEART-VALVE, MECHANICAL
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    February 16, 2001
    Date Received
    January 22, 2001
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    INCREASING THE STERILIZATION LOAD SIZE FOR CPHV(TM) AND UTILIZE MIXED LOADS OF CPHV(TM) AND ANNULOPLASTY RINGS (ANNULOFLO(R), AND/OR ANNULOFLEX(TM), TO MAXIMUM OF 384 BARRIERS IN THE SAME CYCLE AT TH EAUSTIN AND CALGARY FACILITIES.

    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