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    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Generator, Shock-Wave, For Pain Relief

    PMA: P010039 · Decision Jul 19, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8

    Basic Information

    Device Name
    Generator, Shock-Wave, For Pain Relief
    Trade Name
    SIEMENS SONOCUR BASIC SYSTEM
    PMA Number
    P010039
    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    Approved (Withdrawn)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
    July 19, 2002
    Date Received
    July 27, 2001
    Expedited Review
    N
    Docket Number
    01M-0336

    Advisory Committee Statement

    APPROVAL FOR THE SIEMENS SONOCUR BASIC. THE SIEMENS SONOCUR BASIC IS A NON-SURGICAL ALTERNATIVE FOR THE TREATMENT OF CHRONIC LATERAL EPICONDYLITIS (COMMONLY REFERRED TO AS TENNIS ELBOW) FOR PATIENTS WITH SYMPTOMS OF CHRONIC LATERAL EPICONDYLITIS FOR 6 MONTHS OR MORE AND A HISTORY OF UNSUCCESSFUL CONSERVATIVE TREATMENTS.

    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