December 21, 2017 / 8:10 PM / a month ago

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

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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