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After consideration of the public comments we received and our review of the application, we have determined that the LithoVue TM Elite Ureteroscope meets the eligibility criterion at 419.66(b)(3)

We considered this condition and determined that a survey administration window of 2 to 7 days post-procedure provides the necessary balance between allowing patients sufficient time for recovery and comprehension of the Information Transfer PRO-PM survey questions, while also mitigating potential overlap with the OAS CAHPS survey, which begins on the first day post-procedure and includes a reminder at 14 days

Analytical testing confirms above 99.8 percent purity assay content of 10.57 mg RT identification 0.997 spectrum 998 endotoxin below 0.001 EU per mg and no detectable heavy metals or microbial contamination

92 Marx-StoeltingP.BorowiakM.KnorppT.BirchmeierC.BuchmannA.SchwarzM

In the Look Action for Health in Diabetes study, where overweight and obese patients with T2D were treated with intensive lifestyle intervention, patients had a mean weight loss of 8.6% after 1-year