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If you suffer from nausea, vomiting or stomach ache

8 In addition to neuromuscular abnormalities, hyperkalemia may lead to electrocardiogram (ECG) changes

(Wiley, Hoboken, 2015)

FDAs review of a PMA submission is a four-step process that consists of: Administrative and limited scientific review to determine completeness of the application In-depth scientific, regulatory, and quality management system review Panel review by an appropriate advisory committee Final deliberations, documentation, and notification of the FDAs decision FDA will complete its review of the PMA application and advisory committees report and issue a decision within 180 days of the PMA filing