BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pump, Infusion, Implanted, Programmable

    PMA: P860004 · Supplement: S040 · Decision Apr 13, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Pump, Infusion, Implanted, Programmable
    Trade Name
    MEDTRONIC SYNCHROMED INFUSION SYSTEM
    PMA Number
    P860004
    Supplement Number
    S040
    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
    April 13, 1998
    Date Received
    January 15, 1998
    Supplement Type
    Normal 180 Day Track
    Expedited Review
    N

    Advisory Committee Statement

    Approval to modify the prescription caution statement on the SynchroMed prouduct labeling from "Caution: Federal law restricts this device to sale, distribution, and use by or on the order of a physician," to that specified in 21 CFR 801.109(b)(1), "Caution: Federal law restricts this device to sale by or on the order of a physician". FDA also acknowledges and approves the substitution of "(USA)" for "Federal law" for devices distributed outside of the United States.

    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