BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Occluder, Patent Ductus, Arteriosus

    PMA: P000039 · Supplement: S047 · Decision Dec 19, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9

    Basic Information

    Device Name
    Occluder, Patent Ductus, Arteriosus
    Trade Name
    AMPLATZER SEPTAL OCCLUDER
    PMA Number
    P000039
    Supplement Number
    S047
    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
    December 19, 2012
    Date Received
    November 30, 2012
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR LABELING CHANGES REGARDING DEVICE EROSION.

    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