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Per the applicant, the LithoVue TM Elite Ureteroscope meets the requirements at 419.66(b)(3)

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Quality Assurance Standards Each production lot is subjected to rigorous analytical evaluation to meet pharmaceutical-grade specifications

The neurons in the affected network compensate for this weak or absent signals by increasing the number of neuro-transmitter receptors

The commenters stated that CPT code 52597 (0421T) requires greater complexity and more resource than other CPT codes 55880 ( Ablation of malignant prostate tissue, transrectal, with high intensity-focused ultrasound (hifu), including ultrasound guidance ) and 55873 ( Cryosurgical ablation of the prostate (includes ultrasonic guidance and monitoring) ) that are currently in APC 5376 (Level 6 Urology and Related Services)