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Section 5.6 of the Prescribing information indicates, "Cases of bradycardia and cardiac arrest have been reported in Dilantin-treated patients, both at recommended phenytoin doses and levels and in association with phenytoin toxicity

DOI: 10.48550/arXiv.1810.00826 Velickovic, P

Finally, we disagree with the applicant's assertion that the healthcare setting in which procedures utilizing the aprevo Cervical ACDF System device and the aprevo (IFD)are typically performed has relevance to the device category discussion