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    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Generator, Shock-Wave, For Pain Relief

    PMA: P990086 · Decision Oct 12, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8

    Basic Information

    Device Name
    Generator, Shock-Wave, For Pain Relief
    Trade Name
    HEALTHTRONICS OSSATRON
    PMA Number
    P990086
    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    Approved (Withdrawn)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
    October 12, 2000
    Date Received
    December 30, 1999
    Expedited Review
    N
    Docket Number
    01M-0271

    Advisory Committee Statement

    THIS DEVICE IS INDICATED FOR USE FOR PERFORMING EXTRACORPOREAL SHOCK WAVE TREATMENT IN PATIENTS WITH CHRONIC PROXIMAL PLANTAR FASCIITIS THAT HAS FAILED TO RESPOND TO CONSERVATIVE TREATMENT. CHRONIC PROXIMAL PLANTAR FASCIITIS IS DEFINED AS 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