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

    Heart-Valve, Mechanical

    PMA: P900060 · Supplement: S026 · Decision Jul 25, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Heart-Valve, Mechanical
    Trade Name
    CARBOMEDICS PROSTHETIC HEART VALVE {CPHV}
    PMA Number
    P900060
    Supplement Number
    S026
    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
    July 25, 2003
    Date Received
    June 27, 2003
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE IN THE MANUFACTURING PROCESS OF THE PAPER USED IN THE MANUFACTURE OF THE VENT COVERS INCLUDED IN THE PACKAGING OF THE CARBOMEDICS PROSTHETIC HEART VALVE (CPHV).

    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