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

    Stimulator, Bone Growth, Non-Invasive

    PMA: P790002 · Supplement: S036 · Decision Dec 8, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Stimulator, Bone Growth, Non-Invasive
    Trade Name
    BIOMET EBI BONE HEALING SYSTEM
    PMA Number
    P790002
    Supplement Number
    S036
    Device Class
    FDA Class 3
    Product Code
    LOF
    Generic Name
    Stimulator, bone growth, non-invasive
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    December 8, 2016
    Date Received
    November 8, 2016
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Qualification of an alternate supplier to provide electronic printed circuit boards (PCBs) for the three device systems. The change is being made to qualify an alternate secondary-supplier for the PCBs to complement existing approved suppliers in order to further secure the supply chain for critical components to these device systems. The following Zimmer Biomet manufacturing and distribution facility is affected by the changes: EBI Patient Care Inc., Guaynabo, Puerto Rico.

    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