BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    Pulmonary Valve Prosthesis Percutaneously Delivered

    PMA: P200015 · Supplement: S010 · Decision Jun 29, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14

    Basic Information

    Device Name
    Pulmonary Valve Prosthesis Percutaneously Delivered
    Trade Name
    Edwards Commander Delivery System, Crimper
    PMA Number
    P200015
    Supplement Number
    S010
    Product Code
    NPV
    Generic Name
    Pulmonary valve prosthesis percutaneously delivered
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 29, 2021
    Date Received
    June 7, 2021
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a manufacturing site located at Edwards Lifesciences Technology SARL, Hwy #402 N Km 1.4, Añasco, Puerto Rico for ethylene oxide (EO) sterilization of the Commander Delivery System and Crimper accessory for the SAPIEN 3 Transcatheter Heart Valve 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