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Percutaneous Aortic Valve IDE Approval Rests On Clearer Criteria – Edwards

This article was originally published in The Gray Sheet

Executive Summary

Edwards Lifesciences will work with FDA on crafting an acceptable definition for "high-risk patients" to meet an investigational device exemption approval goal of early 2005 for its percutaneous aortic valve, the firm said in a Dec. 3 investor conference

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