BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P900009 · Supplement: S009 · Decision Jun 22, 2000
    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
    SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS) MODEL 2000, EXOGEN 2000
    PMA Number
    P900009
    Supplement Number
    S009
    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
    June 22, 2000
    Date Received
    April 3, 2000
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Express GMP Supplement
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE MANUFACTURING FACILITY AT SMITH & NEPHEW, INC., ORTHOPAEDIC DIVISION, MEMPHIS, TENNESSEE 38116.

    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