BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pump, Infusion, Implanted, Programmable

    PMA: P860004 · Supplement: S060 · Decision Mar 29, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Pump, Infusion, Implanted, Programmable
    Trade Name
    SYNCHROMED II PROGRAMMABLE DRUG INFUSION SYSTEM
    PMA Number
    P860004
    Supplement Number
    S060
    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
    March 29, 2004
    Date Received
    March 24, 2004
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FOLLOWING CHANGES INVOLVING THE MOTOR COIL FOR THE SYNCHROMED II IMPLANTABLE INFUSION PUMP: 1) CHANGE FROM A CRIMPED TO A HEAT-WELDED MOTOR COIL CONNECTOR PIN; AND 2) CHANGE TO A SILICON VARNISH SURFACE COATING OF THE MOTOR COIL, THE SAME COATING AS APPLIED TO THE MOTOR COIL OF THE SYNCHROMED EL IMPLANTABLE 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