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

    Pulmonary Valve Prosthesis Percutaneously Delivered

    PMA: P200015 · Supplement: S037 · Decision Apr 26, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14

    Basic Information

    Device Name
    Pulmonary Valve Prosthesis Percutaneously Delivered
    Trade Name
    Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System
    PMA Number
    P200015
    Supplement Number
    S037
    Product Code
    NPV
    Generic Name
    Pulmonary valve prosthesis percutaneously delivered
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    April 26, 2023
    Date Received
    March 28, 2023
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Reduction of EO residual aeration time for the Commander delivery system.

    Classifications

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

    Product Code Device Name
    NPV Pulmonary Valve Prosthesis Percutaneously Delivered