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Merit Medical Gets 510K Clearance to Market Merit Laureate

Merit Medical Systems, Inc. (Nasdaq: MMSI), a leading manufacturer and marketer of proprietary disposable devices used primarily in cardiology, radiology and endoscopy, today announced that it has received 510(k) clearance from the Food and Drug Administration to market the Merit Laureate® hydrophilic guide wire.

In February 2012, Merit Medical received a warning letter from the FDA regarding modifications in the manufacturing process for which the FDA required additional information. Merit complied by filing a new 510(k) submission.

Posted-In: News FDA

 

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