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In response to our concern whether the LithoVue TM Elite Ureteroscope's MEMS pressure sensor is integral to the services furnished, specifically whether continuous pressure monitoring is required to perform ureteroscopy, the applicant commented that it disagrees with our interpretation of integral and believes that the MEMS pressure sensor is an intrinsic part of the LithoVue TM Elite Ureteroscope because it is not a detachable or an adjunctive component

Therefore, there is no difference between injecting in the abdomen versus over the area of pain when we talk about how the peptide gets to the damaged tissue

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