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This article was originally published in The Gray Sheet

Executive Summary

FDA requests additional information for the firm's VasoSeal premarket approval application, which seeks clearance of the device for facilitating hemostasis following angiography. According to the firm, FDA is asking for more data on the "clinical utility" of the device, "in light of the company's August 1993 amendment" that dropped a proposed angioplasty indication. FDA told Datascope that clinical utility could be demonstrated if the firm broadened the claims or indications for the device and provided supporting data. The Vasoseal PMA was submitted in February 1992 and filed by FDA two months later ("The Gray Sheet" Sept. 6, 1993, p. 10)



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