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doi: 10.1007/s00429-016-1315-9 184 ZhanYYChenYZhangQZhuangJJTianMChenHZet al

Additionally, the applicant asserted that the Uretero1 TM decision makes clear that the lack of such evidence comparing the nominated device to other disposable devices does not and should not preclude an applicant from meeting the substantial clinical improvement standard