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[2] This pharmacokinetic profile affords convenient once-monthly dosing schedules that many patients and practitioners find advantageous, while the use of grapeseed oil may reduce the likelihood of local irritation associated with heavier oils historically used in parenteral hormone products

For the purposes of the device pass-through evaluation process, CMS evaluates the nominated device that is the subject of an application, not a category of devices, to determine if the device meets the eligibility criteria described in 419.66

A finalized public record shows only the methods, fields, and results present for that named lot

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