BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Occluder, Patent Ductus, Arteriosus

    PMA: P020024 · Supplement: S016 · Decision Oct 5, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9

    Basic Information

    Device Name
    Occluder, Patent Ductus, Arteriosus
    Trade Name
    AMPLATZER DUCT OCCLUDER
    PMA Number
    P020024
    Supplement Number
    S016
    Device Class
    FDA Class 3
    Product Code
    MAE
    Generic Name
    OCCLUDER, PATENT DUCTUS, ARTERIOSUS
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 5, 2007
    Date Received
    May 23, 2007
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE MODIFICATION OF THE DEVICE LOAD TEST FROM A MANUAL TO A PARTIALLY AUTOMATED PROCEDURE.

    Classifications

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

    Product Code Device Name
    MAE Occluder, Patent Ductus, Arteriosus