LivaNova PLC (LIVN) Offers Update Following FDA Warning Letter

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Go back to LivaNova PLC (LIVN) Offers Update Following FDA Warning Letter

LivaNova PLC Provides Update on FDA Warning Letter

January 5, 2016 2:15 PM EST

LONDON, Jan. 05, 2016 (GLOBE NEWSWIRE) -- LivaNova PLC (NASDAQ: LIVN) (LSE: LIVN) (the Company) received a Warning Letter dated December 29, 2015, from the United States Food and Drug Administration (FDA) alleging certain violations of FDA regulations applicable to medical device manufacturers at its Munich, Germany and Arvada, Colorado facilities.

The Company currently believes that less than 1 percent of 2016 consolidated sales could be impacted by this Warning Letter, and that FDAs concerns can be resolved without a material impact on the Companys financial results.  Further... More