LivaNova Announces Receipt of Close-Out of Warning Letter from U.S. Food and Drug Administration
“We are pleased to have received the close-out notification from the FDA, and we appreciate the agency’s collaboration throughout this extensive process,” said
Safe Harbor Statement
This news release contains “forward-looking statements” concerning the Company’s goals, beliefs, expectations, strategies, objectives, plans, and underlying assumptions and other statements that are not necessarily based on historical facts. These statements include, but are not limited to, statements regarding the 2015 FDA Warning Letter, the related close-out letter and the 3T Heater-Cooler device. Actual events may differ materially from those indicated in our forward-looking statements as a result of various factors, including those factors set forth in Item 1A of the Company’s most recent Annual Report on Form 10-K, as supplemented by any risk factors contained in Quarterly Reports on Form 10-Q and Current Reports on Form 8-K.
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