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( Based on our review, we continue to believe that the current application lacks sufficient evidence to demonstrate that the VersaVue TM Single-Use Flexible Cystoscope significantly improves clinical outcomes in patients receiving cystoscopy using either reusable scopes or other single-use scopes

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The commenter specifically noted that low payment for PD catheter placement relative to vascular access procedures may create barriers to patients receiving more convenient home-based treatment

Some of these assessments are also done independently