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After consideration of the public comments we received and our review of the application, we have determined that the aprevo Cervical ACDF System meets the newness criterion at 419.66(b)(1)

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"You are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur," the agency added

Clin J Am Soc Nephrol 5 , 21542165 (2010)

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