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Finally, while we maintain our concern regarding the overall utility of the MEMS pressure sensor, we agree with the applicant that the LithoVue TM Elite Ureteroscope, inclusive of the MEMS pressure sensor, meets the criterion because the MEMS pressure sensor is not a detachable or an adjunctive component to the ureteroscope itself, which we previously agreed is necessary and/or required to furnish or deliver the primary procedure (ureteroscopy) with which it is used

The volume of the injection, in milliliters (mL) , can change based on the solutions concentration