BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Occluder, Patent Ductus, Arteriosus

    PMA: P020024 · Supplement: S007 · Decision May 12, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9

    Basic Information

    Device Name
    Occluder, Patent Ductus, Arteriosus
    Trade Name
    AMPLATZER SEPTAL OCCLUDER (ASO) DEVICE, AMPLATZER DUCT OCCLUDER AND AMPLATZER DELIVERY AND EXCHANGE SYSTEM
    PMA Number
    P020024
    Supplement Number
    S007
    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
    May 12, 2006
    Date Received
    November 16, 2005
    Supplement Type
    Real-Time Process
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE USE OF AN ALTERNATE PIGMENT TO BE USED DURING MANUFACTURE OF THE PTFE TUBING COMPONENTS OF THE AMPLATZER DELIVERY AND EXCHANGE SYSTEM SHEATHS, DILATORS AND LOADERS.

    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