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The applicant is only seeking a new device category for transitional pass-through payment status for the LithoVue TM Elite Ureteroscope, a component of the LithoVue TM Elite System

each batch is reviewed for bacterial endotoxins within USP 85 limits

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Ambulatory Surgical Center Covered Procedures List (ASC CPL), contact Abigail Cesnik via email at [email protected]

Toxicity is extremely rare, but injections should still be given under professional guidance

Early complications- The most common complications include small bowel obstruction (1720%), wound infections (5.8%), and bleeding (3.8%)