BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pump, Infusion, Implanted, Programmable

    PMA: P890055 · Supplement: S023 · Decision Nov 26, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Pump, Infusion, Implanted, Programmable
    Trade Name
    CODMAN 3000 IMPLANTABLE INFUSION PUMP
    PMA Number
    P890055
    Supplement Number
    S023
    Device Class
    FDA Class 3
    Product Code
    LKK
    Generic Name
    Pump, infusion, implanted, programmable
    Medical Specialty
    Unknown
    Advisory Committee
    General Hospital
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 26, 2007
    Date Received
    October 23, 2007
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FOLLOWING CHANGES TO THE FLEXTIP PLUS INTRASPINAL CATHETER KIT AND TO THE CODMAN 3000 PUMP ACCESSORIES: 1) REPLACE 3 MM-BEVELED TUOHY NEEDLE WITH A 4 MM-BEVELED TUOHY NEEDLE; 2) REMOVE A RULER; 3) REPLACE REMAINING RULER WITH A NEW RULER; 4) REDUCE AERATION TIME FOR CODMAN 3000 PUMP ACCESSORIES; 5) NEW PACKAGING DESIGN; 6) NEW PACKAGING MATERIALS; 7) UPDATE LABELING TO REFLECT COMPONENT CHANGES; AND 8) CLARIFY ADDITIONAL NON-PYROGENIC COMPONENTS AND PROCEDURAL STEPS.

    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