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This article was originally published in The Gray Sheet

Executive Summary

FDA tells firm that its Oracle-Micro coronary balloon angioplasty-imaging catheter premarket approval application requires "additional data presentation and analysis" on patients currently enrolled in clinical trials, the company says. Endosonics previously reported that it submitted data answering all questions raised by the Circulatory System Devices Advisory Panel in conjunction with its April 1993 recommendation against approving the device ("The Gray Sheet" Jan. 10, I&W-12). FDA's new request is due to "recently implemented PMA clinical data presentation requirements," the company says, noting that it will file a PMA amendment containing the data "as soon as possible"



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