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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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Patients must have a BMI over 30, or a BMI over 27 with one associated condition like hypertension or Type 2 diabetes, and have been unable to lose and keep off weight with lifestyle changes alone (diet, exercise), says Martin

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