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In response to the concern that the data provided did not compare the VersaVue TM Single-Use Flexible Cystoscope to other single-use, disposable cystoscopes, the applicant stated its belief that such evidence would not be relevant to this application, and that CMS did not explain why such evidence is necessary or how it could apply to the application under review

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Regular follow-ups with healthcare providers can help ensure that the treatment remains effective and safe, allowing for any necessary adjustments to be made based on the patient's response