BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pump, Infusion, Implanted, Programmable

    PMA: P860004 · Decision Mar 14, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Pump, Infusion, Implanted, Programmable
    Trade Name
    MEDTRONIC(R) SYNCHROMED(TM) PUMP & INFUSION SYSTEM
    PMA Number
    P860004
    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 14, 1988
    Date Received
    February 3, 1986
    Expedited Review
    N
    Docket Number
    88M-0114

    Advisory Committee Statement

    Approval for the Medtronic® SynchroMed™ Infusion System. This device is indicated for chronic intravascular infusion of floxuridine (FUDR) or doxorubicin hydrochloride (Adriamycin) and, when required bacteriostatic water, physiological saline and/or heparin.

    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