BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pump, Infusion, Implanted, Programmable

    PMA: P890055 · Supplement: S055 · Decision May 22, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Pump, Infusion, Implanted, Programmable
    Trade Name
    MEDSTREAM PROGRAMMABLE INFUSION SYSTEM
    PMA Number
    P890055
    Supplement Number
    S055
    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 22, 2014
    Date Received
    April 28, 2014
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGES TO QUALITY CONTROL AND MANUFACTURING PROCEDURES TO INCLUDE ADDITIONAL STEPS VERIFYING THAT A MINIMUM OF 66 HOURS HAVE ELAPSED BETWEEN THE TIME THAT THE MEDSTREAM PUMP BATTERY IS CONNECTED TO THE PRINTED CIRCUIT BOARD (PCB) AND BEFORE PROGRAMMING THE PCB WITH THE PRODUCTION DIAGNOSTIC PUMP SOFTWARE.

    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