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

    Pump, Infusion, Implanted, Programmable

    PMA: P860004 · Supplement: S386 · Decision Feb 26, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Pump, Infusion, Implanted, Programmable
    Trade Name
    SynchroMed® Infusion System, Ascenda® Intrathecal Catheters
    PMA Number
    P860004
    Supplement Number
    S386
    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
    February 26, 2022
    Date Received
    January 28, 2022
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Process change to the final clean process used in the manufacturing of hybrids and to make operational/procedural changes related to the final clean process at the internal supplier, Medtronic Tempe Campus.

    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