BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Replacement Heart-Valve

    PMA: P870077 · Supplement: S003 · Decision Oct 17, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11

    Basic Information

    Device Name
    Replacement Heart-Valve
    Trade Name
    CARPENTIER-EDWARDS(R) DURAFLEX(TM) BIOPROSTHESIS, MODELS 6625-LP AND 6625 ESR-LP
    PMA Number
    P870077
    Supplement Number
    S003
    Device Class
    FDA Class 3
    Product Code
    DYE
    Generic Name
    replacement Heart-valve
    Regulation Number
    870.3925
    Medical Specialty
    Cardiovascular
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 17, 1996
    Date Received
    April 17, 1996
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    MODIFICATION OF YOUR STERILIZATION PROCESS TO REMOVE AN ASEPTIC STERILANT-TO-STORAGE TRANSFER PROCESS AND REPLACE IT WITH A TERMINAL STEERILIZATION PROCESS

    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