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[11] reported transient motor weakness and transient sensory changes after PCF and believed that excessive pulling, mechanical damage, and thermal damage during drilling were the reasons for weakness or sensory changes after posterior cervical foraminotomy/PECD

As an example, the applicant cited language from the Uretero1 TM decision in which CMS agreed that the device met the criterion for substantial clinical improvement, which stated that while comparative studies between Uretero1 TM and other disposable devices would be helpful, CMS agreed that the evidence demonstrating improved outcomes and reduced patient risk associated with the disposable device in comparison with reusable devices represented substantial clinical improvement (87 FR 71932)

Available: [12] M

Yes, NAD+ Injection requires a prescription from a licensed healthcare provider