BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Pump, Infusion, Implanted, Programmable

    PMA: P860004 · Supplement: S249 · Decision May 13, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Pump, Infusion, Implanted, Programmable
    Trade Name
    SYNCHROMED INFUSION SYSTEM
    PMA Number
    P860004
    Supplement Number
    S249
    Device Class
    FDA Class 3
    Product Code
    LKK
    Generic Name
    Pump, infusion, implanted, programmable
    Medical Specialty
    Unknown
    Advisory Committee
    General Hospital
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    May 13, 2016
    Date Received
    April 13, 2016
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Manufacturing tool change- Medtronic uses a third party vendor to manufacture sub-assembly components. The vendor would like to use a new arbor press which has press force monitoring capabilities, opposed to the current arbor press which does not have such capabilities. The force monitoring will be an internal process, and no device specifications are changed.

    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