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Corvion Receives Breakthrough Device Designation from FDA


Corvion Receives Breakthrough Device Designation from FDA
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WEBSTER, Texas, Dec. 16, 2020 /PRNewswire/ Corvion – developer of fully implanted mechanical circulatory support devices – announced today that it has received Breakthrough Device Designation for its fully implanted Left Ventricular Assist Device (LVAD) from the FDA.  The designation will allow the company to interact with the FDA s experts to efficiently address topics as they arise during product development and testing as well as result in prioritized review of an eventual PMA submission.
This Breakthrough Device Designation is a significant milestone for our company.  In the race to develop the world s first FDA approved fully implanted LVAD, this is a critical step forward.  While others have received the same designation for their proposed fully implanted systems, we are confident no other company has the potential to revolutionize th ....

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