BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Generator, Shock-Wave, For Pain Relief

    PMA: P990086 · Supplement: S003 · Decision Mar 14, 2003
    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
    Supplement Number
    S003
    Device Class
    FDA Class 3
    Product Code
    NBN
    Generic Name
    Generator, shock-wave, for pain relief
    Medical Specialty
    Unknown
    Advisory Committee
    Physical Medicine
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 14, 2003
    Date Received
    November 5, 2001
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    03M-0173

    Advisory Committee Statement

    APPROVAL FOR THE HEALTHTRONICS OSSATRON. THE DEVICE IS INDICATED FOR USE FOR PERFORMING EXTRACORPOREAL SHOCK WAVE (ESW) TREATMENT IN PATIENTS WITH CHRONIC LATERAL EPICONDYLITIS (TENNIS ELBOW) THAT HAS FAILED TO RESPOND TO CONSERVATIVE TREATMENT. CHRONIC LATERAL EPICONDYLITIS IS DEFINED AS LATERAL EPICONDYLITIS THAT HAS PERSISTED FOR 6 MONTHS OR MORE WITH A HISTORY OF UNSUCCESSFUL CONSERVATIVE TREATMENT.

    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