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Comment: With respect to the newness criterion at 419.66(b)(1), the applicant reiterated that the VersaVue TM Single-Use Flexible Cystoscope received 510(k) clearance from FDA on October 6, 2023, and that it submitted an application for pass-through status on February 11, 2025, which is within 3 years of the initial market authorization

B12 is important in making the myelin sheath, which transmits the nerve impulses

Emerging evidence suggests it may reduce inflammatory markers like high-sensitivity C-reactive protein (hsCRP), though whether this represents direct anti-inflammatory action or secondary benefits from metabolic improvements remains under investigation

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