BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Generator, Shock-Wave, For Pain Relief

    PMA: P990086 · Supplement: S004 · Decision Aug 6, 2004
    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
    S004
    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
    August 6, 2004
    Date Received
    February 9, 2004
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR INSERTION OF A TABLE OF ADVERSE EVENTS AND A BRIEF PARAGRAPH FOLLOWING THE POST-APPROVAL STUDY OF ESW TREATMENT OF PLANTAR FASCIITIS CONSTITUTING THE LABELING CHANGES IN THE OPERATING MANUAL.

    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