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The applicant referenced studies comparing the category of single-use cystoscopes to reusable cystoscopes but did not provide evidence that its specific device demonstrates a substantial clinical improvement

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Supplies and preparation Injection supplies: Insulin syringes (typically 0.5mL or 1mL with 29-31 gauge needles) for subcutaneous injection

Comprehensive Aqueous Outflow Procedure The comprehensive aqueous outflow procedure consists of more than 90 degrees of microcatheterization followed by more than 90 degrees of ab interno trabeculotomy used to treat patients with glaucoma