Merit Medical Announces FDA Closeout

South Jordan, Utah-based Merit Medical received a letter from the FDA stating the company has resolved all issues related to a Jan. 30 warning letter, the company said. The warning letter to Merit’s Galway, Ireland, plant, said that modifications to the coating process used for Laureate Hydrophilic Guidewire rendered it an unapproved investigational device. At the time, Merit said it planned to seek 510(k) clearance for the modifications.
Devices & Diagnostics Letter