Edition:
United Kingdom

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


Thursday, 21 Dec 2017 

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. 

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