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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

at 1-844-363-4448 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

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