BRIEF-U.S. FDA Approves Cytosorbents’ Refresh 2 IDE Application With Conditions

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2017-12-21 20:10:41

Dec 21 (Reuters) – Cytosorbents Corp:

* CYTOSORBENTS ACHIEVES KEY MILESTONE WITH FDA APPROVAL OF THE U.S. REFRESH 2 PIVOTAL CARDIAC SURGERY TRIAL IDE APPLICATION

* U.S. FDA GRANTED APPROVAL OF REFRESH 2 INVESTIGATIONAL DEVICE EXEMPTION APPLICATION, WITH CONDITIONS

* CONDITIONS RELATE TO REQUESTED CLARIFICATIONS, CHANGES TO PATIENT CONSENT FORM & INSTRUCTIONS FOR USE DOCUMENT Source text for Eikon: Further company coverage:

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