BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Invasive Bone Growth

    PMA: P850035 · Supplement: S018 · Decision Jan 16, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Stimulator, Invasive Bone Growth
    Trade Name
    EBI SPF IMPLANTABLE SPINAL FUSION STIMULATOR
    PMA Number
    P850035
    Supplement Number
    S018
    Device Class
    FDA Class 3
    Product Code
    LOE
    Generic Name
    Stimulator, invasive bone growth
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 16, 1996
    Date Received
    December 8, 1995
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR REVISIONS TO THE PATIENT BROCHURE TITLED "ANSWERS TO YOUR QUESTIONS ABOUTTHE SPF SPINAL FUSION STIMULATOR." THESE CHANGES INCLUDE DELETION OF SPECIFIC, UNSUBSTNATIATED CLAIMS REGARDING PATIENTS SAFETY AND INCLUSION OF INFORMATION REGARDING DEVICE EXPLANATATION AND MRI WARNING AND PRECAUTION STATEMENTS, AS REQUESTED IN OUR JULY 18, 1995, LETTER

    Classifications

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

    Product Code Device Name
    LOE Stimulator, Invasive Bone Growth