CV Dynamics to resubmit Omnicarbon PMA to FDA within a few months.
This article was originally published in The Gray Sheet
Executive Summary
CV DYNAMICS OMNICARBON CARDIAC VALVE PMA RESUBMISSION will come within the next few months, the company estimates. CV Dynamics plans to submit a revised version of a premarket approval application for the heart valve that was rejected by the agency in 1989. The company plans to supplement the filing with information including updated clinical data and comprehensive fatigue data on the Omnicarbon's pyrolite housing.
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