BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Occluder, Patent Ductus, Arteriosus

    PMA: P120009 · Decision Aug 16, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9

    Basic Information

    Device Name
    Occluder, Patent Ductus, Arteriosus
    Trade Name
    NIT-OCCLUD PDA
    PMA Number
    P120009
    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 16, 2013
    Date Received
    May 4, 2012
    Expedited Review
    N
    Docket Number
    13M-0988

    Advisory Committee Statement

    APPROVAL FOR THE NIT-OCCLUD® PDA. THIS DEVICE IS A PERMANENTLY IMPLANTED PROSTHESIS INDICATED FOR PERCUTANEOUS, TRANSCATHETER CLOSURE OF SMALL TO MODERATE SIZE PATENT DUCTUS ARTERIOSUS WITH A MINIMUMANGIOGRAPHIC DIAMETER LESS THAN 4 MM.

    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