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12 mL/rat/day) or drinking water (12 mL/rat/day) (controls) until they were killed, at 1, 2, 3, 5, 7, 14, 21, 28, 60, and 90 post-operative days

Assuming any necessary clinical data is already available and does not need to be gathered, many companies find that compiling a premarket application (PMA) for a high-risk device often takes 12-24 months, a de novo is 9-12 months, and a 510(k) is 4-6 months

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doi: 10.1016/S1044-0305(02)00376-8

doi: 10.1074/jbc.REV120.009348

Dropping back to the previous dose for two to four weeks and then attempting the escalation again often works