LivaNova (LIVN) Receives FDA Clearance for 3T Heater-Cooler Device Modification
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LivaNova Receives FDA Clearance for 3T Heater-Cooler Device Modification
February 25, 2020 2:00 PM ESTLONDON--(BUSINESS WIRE)-- LivaNova PLC (NASDAQ: LIVN), a market-leading medical technology and innovation company, today announced it received U.S. Food and Drug Administration (FDA) 510(k) clearance for a device modification to its 3T Heater-Cooler® devices. The modification includes the installation of a 3T Aerosol Collection Set, as well as testing that demonstrates the effectiveness of its operating instructions. This modification has been implemented at no cost to customers on devices that have already been distributed and is being implemented on new units being prepared for distribution. Collectively, these modifications further reduce the... More
