Merit Medical Announces FDA Completes Evaluation

FDA says Merit has addressed the violation related to the Merit Laureate(R) Hydrophilic Guidewire.

Merit Medical Systems Inc., a manufacturer and marketer of proprietary disposable medical devices used in interventional and diagnostic procedures, particularly in cardiology, radiology, and endoscopy, announces that the U.S. Food and Drug Administration(FDA) has completed its evaluation of Merit's corrective actions in response to a warning letter issued to the company in January, related to the Merit Laureate(R) Hydrophilic Guidewire. The FDA sent a letter to Merit Medical this week stating that it appears Merit has addressed the violation contained in the warning letter.

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