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Vascular Tissue

FDA renews interim agreement with tissue processing company

Published in Heart Disease Weekly, December 15th, 2002

CryoLife, Inc., (CRY), announced that the U.S. Food and Drug Administration (FDA) has renewed its September 5, 2002, interim agreement with the company.

The renewal allows CryoLife, a pioneer in implantable tissues and surgical adhesives, to continue processing and distributing its cardiac and vascular tissue under the terms of the original agreement for an additional 45 working days, ending January 15, 2003, or until a reinspection is executed and an outcome determined.

As required under terms of the September 5, 2002, interim agreement, CryoLife submitted its corrective action plan on October 5, 2002, to the FDA and has requested an FDA...

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