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

    Pump, Infusion, Implanted, Programmable

    PMA: P890055 · Supplement: S061 · Decision Oct 8, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Pump, Infusion, Implanted, Programmable
    Trade Name
    MEDSTREAM AND CODMAN 3000 IMPLANTABLE INFUSION PUMP
    PMA Number
    P890055
    Supplement Number
    S061
    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
    October 8, 2015
    Date Received
    September 8, 2015
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGES TO THE STERILIZATION PROCESS: 1) STEAM INJECTION RATE CURRENTLY AT 20 MBAR/MIN WILL CHANGE TO 5 MBAR/MIN; 2) GAS INJECTION RATE CURRENTLY AT 25 MBAR/MIN WILL CHANGE TO 20 MBAR/MIN; 3) MINIMUM PRIMARY DEGASSING TIME OF 10 HOURS WILL CHANGE TO 8 HOURS; 4) THE HANDLES FROM THE STERILIZATION SHIPPER, NUMBER 197548018, WILL BE REMOVED; 5) ADD A SECOND ETHYLENE OXIDE (EO) STERILIZATION CHAMBER (CHAMBER #4; 6) A MINIMUM EO STERILIZATION LOAD IN CHAMBER #3 (EXISTING CHAMBER) AND CHAMBER #4; AND 7) A 2X EO STERILIZATION FOR BOTH CHAMBER #3 AND #4.

    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