Published in Medical Letter on the CDC and FDA, January 14th, 2007
The company expects to respond to such comments within the next 30 days. As a consequence of the continued review of the company's application, the company no longer expects to receive 510(k) clearance on a timeline that would permit commercial launch of its minimally invasive system this calendar year.
MedicalCV, Inc., a cardiovascular surgery device manufacturer, focuses on the development and introduction of products designed for early treatment of...
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