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In Brief: U.S. Surgical

This article was originally published in The Gray Sheet

Executive Summary

U.S. Surgical: Maintains in Oct. 14 comments to FDA that it has legal authority to seek rejection of Sofamor Danek's premarket approval application for its Novus LC threaded interbody fusion system. USSC petitioned FDA in July to turn down the Novus PMA because it lacks two-year follow-up data, and Sofamor Danek responded by claiming that USSC could not participate in the review process and that FDA did not have a two-year rule ("The Gray Sheet" Aug. 11, I&W-3). FDA has "created a de facto policy requiring such data" and has "consistently enforced this policy over the years with respect to orthopedic implantable devices," USSC maintains...



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