Merit Medical Systems, a disposable medical device company based in South Jordan, Utah, received a warning letter from the FDA over changes it made to its Merit Laureate Guidewire, which is designed to help physicians place other medical devices, such as catheters, in blood vessels, according to a Salt Lake Tribune report.
FDA expressed concern over changes made to the coating of the guidewire, which is manufactured at the company's plant in Galway, Ireland. Fred Lampropoulos, Merit's chairman and CEO, said the company didn't think it needed additional approval for such a change but would work with the FDA to resolve the issue.
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FDA expressed concern over changes made to the coating of the guidewire, which is manufactured at the company's plant in Galway, Ireland. Fred Lampropoulos, Merit's chairman and CEO, said the company didn't think it needed additional approval for such a change but would work with the FDA to resolve the issue.
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