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This article was originally published in The Gray Sheet

Executive Summary

Inamed/BioEnterics hope that results of a 50-patient trial of the Lap-Band laproscopic adjustable gastric band for the treatment of morbid obesity will help persuade CMS to redefine obesity as an illness, and not just a co-morbidity, for the purposes of coverage decisions. CMS has extended the deadline for a decision to May 30. Meanwhile, the firm is on track to receive PMA approval for its silicone-gel breast implant this year. Development of the second-generation Style 410 implant is ongoing. "The Gray Sheet" (April 1, p. 29) incorrectly reported that the Style 410 would be approved in 2002...



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