BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Generator, Shock-Wave, For Pain Relief

    PMA: P040039 · Decision Aug 10, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8

    Basic Information

    Device Name
    Generator, Shock-Wave, For Pain Relief
    Trade Name
    ORBASONE PAIN RELIEF SYSTEM
    PMA Number
    P040039
    Device Class
    FDA Class 3
    Product Code
    NBN
    Generic Name
    Generator, shock-wave, for pain relief
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    August 10, 2005
    Date Received
    September 14, 2004
    Expedited Review
    N
    Docket Number
    05M-0339

    Advisory Committee Statement

    APPROVAL FOR THE ORBASONE PAIN RELIEF SYSTEM. THE DEVICE IS INDICATED FOR EXTRACORPOREAL SHOCK WAVE THERAPY FOR THE TREATMENT OF CHRONIC PROXIMAL PLANTAR FASCIITIS IN PATIENTS 18 YEARS OF AGE OR OLDER THAT HAVE FAILED TO RESPOND TO CONSERVATIVE THERAPY. CHRONIC PROXIMAL PLANTAR FASCIITIS IS DEFINED AS HEEL PAIN IN THE AREA OF THE INSERTION OF THE PLANTAR FASCIA ON THE MEDIAL CALCANEAL TUBEROSITY THAT HAS PERSISTED FOR SIX MONTHS OR MORE.

    Classifications

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

    Product Code Device Name
    NBN Generator, Shock-Wave, For Pain Relief