BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pump, Infusion, Implanted, Programmable

    PMA: P860004 · Supplement: S041 · Decision Dec 4, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Pump, Infusion, Implanted, Programmable
    Trade Name
    MEDTRONIC SYNCHROMED PUMP HYBRID
    PMA Number
    P860004
    Supplement Number
    S041
    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
    December 4, 1998
    Date Received
    November 9, 1998
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for modifications to the device: 1) Replacement of the quartz crystal oscillator with a surface mount crystal oscillator with the same electrical operating specifications, 2) Replacement of the ceramic wiring board with a fiberglass printed wiring board, 3)Mounting the antenna/reedswitch assembly directly on the wiring board 4) Replacement of the ceramic chip carrier packaging of the microprocessor and integrated circuit with plastic packages, 5) Attachment of the hybrid printed wiring board to the pump center plate with two sided, acrylic adhesive tape rather than a bracket and plastic cup assembly.

    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