BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Bone Growth, Non-Invasive

    PMA: P910066 · Supplement: S016 · Decision May 18, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17

    Basic Information

    Device Name
    Stimulator, Bone Growth, Non-Invasive
    Trade Name
    OL1000/OL1000 SC/SPINALOGIC BONE GROWTH STIMULATORS
    PMA Number
    P910066
    Supplement Number
    S016
    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
    May 18, 2001
    Date Received
    April 11, 2001
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO: 1)REFORMAT THE PATIENT MANUALS FOR THE OL 1000 AND OL 1000 SC BONE GROWTH STIMULATORS PER THE RECENT CDRH GUIDANCE ON MEDICAL DEVICE LABELING, 2) REFORMAT THE PATIENT MANUAL FOR THE SPINALOGIC(TM) BONE GROWTH STIMULATOR PER THE RECENT CDRH GUIDANCE ON MEDICAL DEVICE LABELING.

    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