BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Bone Growth, Non-Invasive

    PMA: P190030 · Supplement: S003 · Decision Nov 13, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Stimulator, Bone Growth, Non-Invasive
    Trade Name
    ActaStim-S Spine Fusion Stimulator
    PMA Number
    P190030
    Supplement Number
    S003
    Device Class
    FDA Class 3
    Product Code
    LOF
    Generic Name
    Stimulator, bone growth, non-invasive
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 13, 2024
    Date Received
    August 15, 2024
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for minor changes to the device’s Instructions for Use to indicate that the device provides 270 days of continuous treatment, to revise the instructions to the user upon completion of treatment, and to indicate that the ActaStim-S system, excluding consumables, has an expected lifetime of three years.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LOF Stimulator, Bone Growth, Non-Invasive