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South Jordan – Merit Medical Systems, Inc. has received approval from the Chinese Food and Drug Administration (CFDA) to market its Aero Tracheobronchial Stent System. The approval is for a period of five years and includes the "over-the-wire" system as well as the "direct visualization" system. The approval covers 33 catalog items.
"This approval is our initial entry of Merit's Endotek division into China," said Fred P. Lampropoulos, Merit's chairman and CEO. "The Aero stent product line has become the market leader in many areas of the world. Our hope is that we will have the same result in China."
The product licenses are owned and maintained by Merit and will be distributed by a select group of dealers with support from Merit's marketing and clinical group.
Merit manufactures and markets proprietary disposable medical devices.