BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Generator, Shock-Wave, For Pain Relief

    PMA: P990086 · Supplement: S001 · Decision May 1, 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
    S001
    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
    May 1, 2001
    Date Received
    October 19, 2000
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE POST MARKET APPROVAL STUDY PROTOCOL.

    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