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

    PMA: P200046 · Supplement: S020 · Decision Sep 19, 2023
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    Harmony™ Transcatheter Pulmonary Valve
    PMA Number
    P200046
    Supplement Number
    S020
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    September 19, 2023
    Date Received
    September 5, 2023
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Relocation of the alpha-amino oleic acid (AOA) solution formulation process from ISO Class 7 Controlled Environment Area (CEA) 31 to ISO Class 8 CEA 33.