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Identification and cloning of a beta-cell-specific zinc transporter, ZnT-8, localized into insulin secretory granules

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The applicant stated that the distal tip of the LithoVue TM ( Elite Ureteroscope's shaft includes the working channel, the illumination optics, the digital imaging sensor, and a Micro-Electro-Mechanical Systems (MEMS) pressure sensor for monitoring the real-time intraluminal pressure during ureteroscopy

FDA staff said they had considered everything submitted by the meeting deadline and would still take new information into account as they weigh next steps