Abstract: Highwayengineeringfeasibilitystudyreportiscriticalof the preliminarywork of roadconstruction and an importantbasis forprojectapprovalandpost-constructiondrawingdesign.
HeartWare said that the FDA was requiring the company to perform a post-approval study in the form of a registry consisting of 600 HeartWare patients and an additional 600 control patients.