BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Generator, Shock-Wave, For Pain Relief

    PMA: P990086 · Supplement: S002 · Decision Mar 30, 2001
    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
    S002
    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 30, 2001
    Date Received
    January 12, 2001
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CERTAIN ERGONOMIC AND SAFETY DESIGN CHANGES AND A DEVICE PERFORMANCE CHANGE, I.E., PROVIDING THE OPTION OF USING 4 HZ FREQUENCY OF THE SHOCK WAVE DELIVERY, AS WELL AS LABELING CHANGES IN THE OPERATOR MANUAL TO PROVIDE ADEQUATE INSTRUCTIONS AND INFORMATION ABOUT THESE CHANGES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HEALTHTRONICS OSSATRON(R) AND IS INDICATED FOR USE FOR PERFORMING EXTRACORPOREAL SHOCK WAVE (ESW) TREATMENT IN PATIENTS WITH CHRONIC PROXIMAL PLANTAR FASCIITIS THAT HAVE FAILED TO RESPOND TO CONSERVATIVE TREATMENT. CHRONIC PROXIMAL PLANTAR FASCIITIS IS DEFINED AS PAIN IN THE AREA OF 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