BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pump, Infusion, Implanted, Programmable

    PMA: P860004 · Supplement: S035 · Decision Sep 10, 1996
    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
    S035
    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
    September 10, 1996
    Date Received
    May 8, 1996
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO ADD TO THE LABELING FOR THE 10 CC SYNCHROMED IMPLANTABLE PROGRAMMABLE INFUSION PUMP, MOELS 8616-10 AND 8617-10 THE FOLLOWING INDICATIONS:1)THE CHRONIC INTRASPINAL (EPIDURAL/INTRATHECAL) INFUSION OF PRESERVATIVE-FREE MORPHINE SULFATE STERILE SOLUTION IN THE TREATEMTN OF CHRONIC INTRACTABLE PAIN; 2)THE CHRONIC INTRAVASCULAR INFUSION OF FLOXURIDINE, DOXORUBICIN, CISPLATIN, OR METHOTREXATE FOR THE TREATEMENT OF PRIMARY OR METASTATIC CANCER; AND 3)THE INTRAVENOUS INFUSION OF CLINDAMYCIN FOR THE TREATMENT OF OSTEOMYELITIS

    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