BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Pump, Infusion, Implanted, Programmable

    PMA: P860004 · Supplement: S148 · Decision Mar 22, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Pump, Infusion, Implanted, Programmable
    Trade Name
    SYNCHROMED II INFUSION PUMP
    PMA Number
    P860004
    Supplement Number
    S148
    Device Class
    FDA Class 3
    Product Code
    LKK
    Generic Name
    Pump, infusion, implanted, programmable
    Medical Specialty
    Unknown
    Advisory Committee
    General Hospital
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    March 22, 2011
    Date Received
    February 28, 2011
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    ADDITION OF TWO NEW LASER WELDING WORKSTATIONS AND TWO NEW LASER POWER SUPPLIES TO THE MANUFACTURING PROCESS OF THE IMPLANTABLE SYNCHROMED II INFUSION PUMP, MODEL 8637.

    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