BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pump, Infusion, Implanted, Programmable

    PMA: P860004 · Supplement: S042 · Decision Mar 18, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Pump, Infusion, Implanted, Programmable
    Trade Name
    MEDTRONIC SYNCHROMED IMPLANTABLE INFUSION PUMP
    PMA Number
    P860004
    Supplement Number
    S042
    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 18, 1999
    Date Received
    February 26, 1999
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for addition of an alternate catheter port for use with the SynchroMed pump, Model 8508 CAP; Addition of an Application Specific Integrated Circuit (ASIC) buffer chip to the pumps hybrid to improve battery longevity; addition of another suture loop to the shield; change in the device name from SynchroMed(TM) to SynchroMed EL(TM); change in model numbers (new model numbers represent new SynchroMed EL Pumps); and change to labeling.

    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