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REVA Completes Submission of CE Mark Application

REVA Medical, Inc. is pleased to announce that it has submitted an application for CE Marking of its Fantom scaffold, following completion of clinical data analyses and required testing. The regulatory approval process generally spans several months and includes evaluation of the clinical, preclinical, and bench test data submitted, as well as audits of the Company’s quality assurance system and related processes. Accordingly, the Company expects it would receive CE Mark approval, or notice of any issues with the application, prior to December 31, 2016. This regulatory approval would allow commercial sales in Europe and other countries that recognize the CE Mark.

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