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

    Shunt, Portosystemic, Endoprosthesis

    PMA: P040027 · Supplement: S034 · Decision Jul 2, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10

    Basic Information

    Device Name
    Shunt, Portosystemic, Endoprosthesis
    Trade Name
    GORE VIATORR TIPS ENDOPROSTHESIS
    PMA Number
    P040027
    Supplement Number
    S034
    Device Class
    FDA Class 3
    Product Code
    MIR
    Generic Name
    SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    July 2, 2014
    Date Received
    June 4, 2014
    Supplement Type
    30-Day Notice
    Expedited Review
    N

    Advisory Committee Statement

    IMPLEMENTATION OF FOURIER TRANSFORM INFRARED SPECTROSCOPY, BACTERIALENDOTOXIN TESTING, HEAVY METALS AS LEAD (HMAL) AND NON-VOLATILE RESIDUE (NVR) TESTING IN THE EAST COAST TESTING CENTER.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MIR Shunt, Portosystemic, Endoprosthesis