BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pump, Infusion, Implanted, Programmable

    PMA: P860004 · Supplement: S056 · Decision Sep 12, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Pump, Infusion, Implanted, Programmable
    Trade Name
    SYNCHROMED II PROGRAMMABLE DRUG INFUSION SYSTEM
    PMA Number
    P860004
    Supplement Number
    S056
    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
    September 12, 2003
    Date Received
    April 7, 2003
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE MEDTRONIC SYNCHROMED II PROGRAMMABLE DRUG INFUSION SYSTEM WHICH INCLUDES MODEL 8637 SYNCHROMED II PROGRAMMABLE PUMP, SYNCHROMED II APPLICATION SOFTWAARE ON THE MODEL 8870 APPLICATION CARD, MODEL 8551 REFILL KIT, MODEL 8540 CATHETER ACCESS PORT KIT, AND MODEL 8590-1 POUCH KIT.

    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