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As previously noted, the applicant is only seeking a new device category for transitional pass-through payment status for the LithoVue TM Elite Ureteroscope component of the LithoVue TM Elite System, and as such, the eligibility and exclusion criteria will evaluate the LithoVue TM Elite Ureteroscope

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High Lp(a) is usually asymptomatic, with no noticeable symptoms until it is too late

The majority of patients (67%) with CGD harbor mutations in an X-chromosome gene (CYBB) that encodes the -subunit (gp91-PHOX) of cytochrome b 558