EnSite to take PMA (Pre-market Approval) route for left ventricle mapping
This article was originally published in Clinica
Endocardial Solutions, which is pursuing US FDA approval for its EnSite 3000 three-dimensional mapping system for investigating cardiac arrhythmias, has said that its application for left ventricular use of the device will now be submitted as a premarket approval application. The company had filed a 510(k) application for left ventricular use last December.
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