BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pump, Infusion, Implanted, Programmable

    PMA: P860004 · Supplement: S243 · Decision Jul 22, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Pump, Infusion, Implanted, Programmable
    Trade Name
    SYNCHROMED II IMPLANTABLE INFUSION PUMP
    PMA Number
    P860004
    Supplement Number
    S243
    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
    July 22, 2016
    Date Received
    November 10, 2015
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a software change to the Model 8870 Application Software Card to reduce the fixed, default Tubing Volume displayed on the priming bolus screen from 0.199 mL to 0.140 mL. This software card is used in the Model 8840 Clinician Programmer to program the Model 8637 SynchroMed II infusion pump. This change is applicable to the full system priming bolus function of the Model 8840 Clinician Programmer to program the Model 8637 SynchroMed II infusion pump. Labeling changes are also being made in the Instructions for Prescribers, Implant Manual and Clinician Programmer Guide to reflect the software change

    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