Advertisement
Advertisement
September 23, 2012
Merit Medical's Laureate Hydrophilic Guidewire Cleared by FDA
September 24, 2012—Merit Medical Systems, Inc. (South Jordan, UT) announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) to market the Merit Laureate hydrophilic guidewire.
The company advised that in February 2012 it received a warning letter from the FDA about modifications in the manufacturing process of the device—which is manufactured in Galway, Ireland—and additional information required by the FDA. Merit complied by filing a new 510(k) submission. Merit noted that it discontinued sales of the Merit Laureate during the review period in the United States, but continued to market the product in international markets.
Advertisement
Advertisement
