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Baseline Health Assessment : Including cardiovascular evaluation, metabolic panel, and hormone level assessment to establish pre-study baselines

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Further, the applicant explained that it did not assert that the VersaVue TM Single-Use Flexible Cystoscope offers a substantial clinical improvement compared to other single-use cystoscopes, stating that the substantial clinical improvement claims and evidence provided were in support of the category of single-use cystoscopes compared to reusable cystoscopes rather than the VersaVue TM Single-Use Flexible Cystoscope compared to other single-use, disposable cystoscopes or reusable cystoscopes