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

    Pump, Infusion, Implanted, Programmable

    PMA: P890055 · Supplement: S077 · Decision Apr 13, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Pump, Infusion, Implanted, Programmable
    Trade Name
    Intera 3000 Hepatic Artery Infusion Pump accessories
    PMA Number
    P890055
    Supplement Number
    S077
    Device Class
    FDA Class 3
    Product Code
    LKK
    Generic Name
    Pump, infusion, implanted, programmable
    Medical Specialty
    Unknown
    Advisory Committee
    General Hospital
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    April 13, 2021
    Date Received
    March 26, 2021
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Change in the firms responsible for receiving and inspection activities for the barbed connector and tapered catheter components, cleaning and passivating of the barbed connector component, and packaging, sealing, and labeling of the barbed connector and tapered catheter components for the Intera 3000 Hepatic Artery Infusion Pump.

    Classifications

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

    Product Code Device Name
    LKK Pump, Infusion, Implanted, Programmable