BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Occluder, Patent Ductus, Arteriosus

    PMA: P020024 · Decision May 14, 2003
    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
    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 14, 2003
    Date Received
    June 24, 2002
    Expedited Review
    N
    Docket Number
    06M-0075

    Advisory Committee Statement

    APPROVAL FOR THE AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEM. THE PERCUTANEOUS, TRANSCATHETER OCCLUSION DEVICE IS INDICATED FOR THE NON-SURGICAL CLOSURE OF PATENT DUCTUS ARTERIOSUS (PDA).

    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