BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pump, Infusion, Implanted, Programmable

    PMA: P860004 · Supplement: S061 · Decision Jun 4, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Pump, Infusion, Implanted, Programmable
    Trade Name
    SYNCHROMED IMPLANTABLE INFUSION SYSTEM
    PMA Number
    P860004
    Supplement Number
    S061
    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
    June 4, 2004
    Date Received
    May 19, 2004
    Supplement Type
    Special (Immediate Track)
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A CHANGE TO THE MEDTRONIC MODEL 8840 N'VISION PROGRAMMER TECHNICAL MANUAL TO ADD A PRECAUTION TO IDENTIFY AN ENVIRONMENT IN WHICH THE DEVICE IS NOT CERTIFIED 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