BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pump, Infusion, Implanted, Programmable

    PMA: P860004 · Supplement: S051 · Decision May 14, 2002
    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
    S051
    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
    May 14, 2002
    Date Received
    April 29, 2002
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FOLLOWING CHANGES TO INTRATHECAL CATHETER MODEL 8711: 1) ADDITION OF NUMERICAL MARKINGS (IN CM) ON THE CATHETER TUBING, 2) CHANGE IN V-WING ANCHOR MATERIAL FOR IMPROVED VISIBILITY, 3) REMOVAL OF PROXIMAL ANCHOR; TUNNELING ROD TIPS AND WRENCH FROM THE CATHETER KIT, AND 4) UPDATE MODEL 8711 TECHNICAL MANUAL TO PROVIDE DETAILED INSTRUCTIONS AND CAUTIONS.

    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