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

    Pump, Infusion, Implanted, Programmable

    PMA: P860004 · Supplement: S450 · Decision Sep 18, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Research PMA P860004 in seconds

    The Research Assistant summarizes PMA approval history, supplements and related safety signals — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Pump, Infusion, Implanted, Programmable
    Trade Name
    SynchroMed® Infusion System, Ascenda® Intrathecal Catheters (Drug Delivery Infusion Pump 8667); (Drug Delivery Infusion
    PMA Number
    P860004
    Supplement Number
    S450
    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
    September 18, 2025
    Date Received
    August 19, 2025
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    approval for updates to the medium rate battery manufacturing process

    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