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The applicant asserted that, by creating a new device category and code, CMS will ensure that claims for the Axoguard HA+ Nerve Protector TM can be accurately identified, and thus, improve transparency and allow the collection of meaningful data regarding the device's cost and performance during the transitional pass-through period, as intended under 419.66

Stop use and seek medical advice if you develop rash, shortness of breath, chest pain, severe swelling, persistent vomiting, or any unexpected or worsening symptoms