BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pump, Infusion, Implanted, Programmable

    PMA: P890055 · Supplement: S012 · Decision Apr 24, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Pump, Infusion, Implanted, Programmable
    Trade Name
    ARROW OR PUMP HEATER & AP-07009 FLEX TIP PLUS INTRASPINAL KIT
    PMA Number
    P890055
    Supplement Number
    S012
    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
    April 24, 2001
    Date Received
    April 2, 2001
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF: 1) AN OR PUMP HEATER (AP-09100) AND DRAPE (AP-09150) AS AN OPTION TO THE TRADITIONAL WATER BATH; 2) A MICROPIPETTE OR PREP KIT (AP-07004) FOR THE MEASUREMENT OF FLOW FROM THE IMPLANTABLE PUMP PRIOR TO IMPLANTATION; AND 3) ACCESSORIES TO THE INTRASPINAL KIT (AP-07009), INCLUDING AN ADDITIONAL NEEDLE AND BOTH WINGED AND TRADITIONAL CATHETER ANCHORS.

    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