BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep

    PMA: P900009 · Supplement: S012 · Decision Feb 21, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep
    Trade Name
    EXOGEN 3000 SONIC ACCELERATED FRACTURE HEALING SYSTEM
    PMA Number
    P900009
    Supplement Number
    S012
    Device Class
    FDA Class 3
    Product Code
    LPQ
    Generic Name
    Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 21, 2001
    Date Received
    October 12, 2000
    Supplement Type
    Normal 180 Day Track
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A CHANGE IN LABELING FOR THE EXOGEN 3000(R), TO INCORPORATE BOTH THE FRESH FRACTURE AND NONUNION INFORMATION INTO ONE SET OF PHYSICIAN'S INSTRUCTIONS FOR USE, PATIENT'S INSTRUCTIONS FOR USE, AND PRODUCT INSERT BULLETIN; TO MAKE MANUAL SIZE AND FORMATTING CHANGES, AND TO ADD NONUNION BACKGROUND INFORMATION.

    Classifications

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

    Product Code Device Name
    LPQ Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep