BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Generator, Shock-Wave, For Pain Relief

    PMA: P080028 · Decision Jan 8, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8

    Basic Information

    Device Name
    Generator, Shock-Wave, For Pain Relief
    Trade Name
    STORZ MEDICAL DUOLITH SD1 SHOCK WAVE THERAPY
    PMA Number
    P080028
    Device Class
    FDA Class 3
    Product Code
    NBN
    Generic Name
    Generator, shock-wave, for pain relief
    Medical Specialty
    Unknown
    Advisory Committee
    General, Plastic Surgery
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 8, 2016
    Date Received
    November 26, 2008
    Expedited Review
    N
    Docket Number
    16M-0122

    Advisory Committee Statement

    APPROVAL FOR THE STORZ MEDICAL DUOLITH SD1 SHOCK WAVE THERAPY. THIS DEVICE IS INDICATED FOR EXTRACORPOREAL SHOCK WAVE TREATMENT OF HEEL PAIN DUE TO CHRONIC PROXIMAL PLANTAR FASCIITIS FOR PATIENTS OF AGE GREATER THAN 18 YEARS WITH A HISTORY OF FAILED ALTERNATIVE CONSERVATIVE THERAPIES FOR AT LEAST SIX MONTHS. CHRONIC PROXIMAL PLANTAR FASCIITIS IS DEFINED AS TRACTION DEGENERATION OF THE PLANTAR FASCIAL BAND AT THE ORIGIN 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