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Additionally, FDA cited Zoll for failing to follow MDR reporting requirements, including incidents where there may have been a reasonable concern of a product malfunction, and the company didn't notify the agency within the required timeframe

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In the SUSTAIN trials, the patients enrolled were predominantly white (61% to 84%) with a mean BMI per group ranging from 32 kg/m 2 to 34 kg/m 2 , and with body weight ranging from 89 kg to 97 kg

Psychoneuroendocrinology 117, 104687