BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Occluder, Patent Ductus, Arteriosus

    PMA: P020024 · Supplement: S057 · Decision Aug 22, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9

    Basic Information

    Device Name
    Occluder, Patent Ductus, Arteriosus
    Trade Name
    AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEM
    PMA Number
    P020024
    Supplement Number
    S057
    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
    August 22, 2019
    Date Received
    June 24, 2019
    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 an alternate sterilization site at Midwest Sterilization Corporation, 1204 Lenco Avenue, Jackson, Missouri.

    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