Merit Medical passes US FDA 510(K) clearance for the Elation Pulmonary Dilation Balloon.
M2 PHARMA-September 8, 2016-Merit Medical passes US FDA 510(K) clearance for the Elation Pulmonary Dilation Balloon
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Merit Medical Systems (NasdaqGS:MMSI) reported on Wednesday the receipt of the 510(k) clearance from the Food and Drug Administration (US FDA) for its Elation Pulmonary Dilation Balloon.
The company said the Elation Pulmonary Dilation Balloon is used to endoscopically dilate strictures of the trachea or bronchi.
Founded in 1987, the company is engaged in the development, manufacture and distribution of proprietary disposable medical devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology and endoscopy.
In addition, the company serves client hospitals with a domestic and international sales force of 200 individuals. It employs 4,000 people worldwide with facilities in South Jordan, Utah; Pearland, Texas; Richmond, Virginia; Malvern, Pennsylvania; Rockland, Massachusetts; San Jose, California; Maastricht and Venlo, The Netherlands; Paris, France; Galway, Ireland; Beijing, China; Tijuana, Mexico; Joinville, Brazil; Markham, Ontario, Canada; Melbourne, Australia and Mannheim, Germany.
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|Date:||Sep 8, 2016|
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