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CryoLife BioGlue

This article was originally published in The Gray Sheet

Executive Summary

Investigational device exemption supplement is submitted to expand studies of the surgical adhesive to include use in vascular and certain cardiac repairs in addition to the commercially approved use as an adjunct in acute thoracic aortic dissections, cited in the original June 1998 IDE. A December FDA Humanitarian Device Exemption approval covers the latter indication, and shipments commenced Jan. 3 (1"The Gray Sheet" Dec. 20, p. 24)

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