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We stated that we welcome additional information that compares outcome data from the Axoguard HA+ Nerve Protector TM and the predicate device, the Axoguard Nerve Protector TM , to help inform our assessment of whether the Axoguard HA+ Nerve Protector TM demonstrates a substantial clinical improvement

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Radevski, F., Peraic, P., Maek, T., Starevi, K., Krezic, I., Pavlov, K., Drmic, D., Kralj, T., Seiwerth, S., Sikiric, P., & Kokot, A