BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pump, Infusion, Implanted, Programmable

    PMA: P860004 · Supplement: S202 · Decision Feb 25, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Pump, Infusion, Implanted, Programmable
    Trade Name
    MEDTRONIC IMPLANTABLE PROGRAMMABLE INFUSION PUMPS
    PMA Number
    P860004
    Supplement Number
    S202
    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
    February 25, 2014
    Date Received
    January 28, 2014
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR DEVICE REFILL KIT MODEL 8551TO REORDER THE WARNINGS AND PRECAUTIONS ACCORDING TO MEDICAL IMPORTANCE, TO REMOVE INFORMATION FOUND IN THE PREVIOUSLY APPROVED INSTRUCTIONS FOR USE THAT IS NOT APPLICABLE TO MODEL 8551, AND TO ALIGN VERBIAGE WITH THE UPDATED MODEL 856X REFILL KIT INSTRUCTIONS FOR USE.

    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