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    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Generator, Shock-Wave, For Pain Relief

    PMA: P000048 · Decision Jan 15, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8

    Basic Information

    Device Name
    Generator, Shock-Wave, For Pain Relief
    Trade Name
    DORNIER EPOS ULTRA
    PMA Number
    P000048
    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    Approved (Withdrawn)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
    January 15, 2002
    Date Received
    November 21, 2000
    Expedited Review
    N
    Docket Number
    02M-0034

    Advisory Committee Statement

    APPROVAL FOR THE DORNIER EPOS ULTRA. THE DORNIER EPOS ULTRA IS A NON-SURGICAL ALTERNATIVE FOR THE TREATMENT OF CHRONIC PLANTAR FASCIITIS FOR PATIENTS WITH SYMPTOMS OF PLANTAR FASCIITIS FOR 6 MONTHS OR MORE AND A HISTORY OF UNSUCCESSFUL CONSERVATIVE THERAPY. PLANTAR FASCIITIS IS DEFINED AS THE TRACTION DEGENERATION OF THE PLANTAR FASCIAL BAND AT ITS ORIGIN ON THE MEDICAL TUBERCLE OF THE CALCANEUS.

    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