BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Occluder, Patent Ductus, Arteriosus

    PMA: P020024 · Supplement: S043 · Decision Apr 12, 2016
    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
    S043
    Device Class
    FDA Class 3
    Product Code
    MAE
    Generic Name
    OCCLUDER, PATENT DUCTUS, ARTERIOSUS
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    April 12, 2016
    Date Received
    March 14, 2016
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Addition of two new ethylene oxide sterilization chambers at the approved contract sterilizer.

    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