BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pump, Infusion, Implanted, Programmable

    PMA: P860004 · Supplement: S138 · Decision Mar 3, 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 SYSTEM
    PMA Number
    P860004
    Supplement Number
    S138
    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 3, 2011
    Date Received
    August 10, 2010
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL OF THE FOLLOWING MANUFACTURING PROCESS CHANGES RELATED TO THE BASELINE TEST OF THE IMPLANTABLE SYNCHROMED II INFUSION PUMP, MODEL 8637: 1) AUTOMATION OF THE TRANSFER OF BASELINE TEST DATA; 2) CHANGE THE DUTY CYCLE AND LOWER THE SPECIFICATION LIMIT OF THE DYNAMIC CURRENT TEST; AND 3) AN INCREASE TO THE TIME TO MEASURE THE MICRO AWAKE CURRENT.

    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