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

    Replacement Heart-Valve

    PMA: P870077 · Supplement: S008 · Decision Oct 26, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11

    Basic Information

    Device Name
    Replacement Heart-Valve
    Trade Name
    CARPENTIER-EDWARDS DURAFLEX BIOPROSTHESIS MODELS 6625LP AND 6625 LP-ESR
    PMA Number
    P870077
    Supplement Number
    S008
    Device Class
    FDA Class 3
    Product Code
    DYE
    Generic Name
    replacement Heart-valve
    Regulation Number
    870.3925
    Medical Specialty
    Cardiovascular
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    October 26, 1998
    Date Received
    October 9, 1998
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    The 30-day notice requested a change in the incubation period for the Test of Sterility (of both the sterilant solution and of sterilized products) to reduce the total time required to manufacture the bioprostheses.

    Classifications

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

    Product Code Device Name
    DYE Replacement Heart-Valve