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Novoste Meeting With FDA On Beta-Cath Labeling Issues Week Of Oct. 23

This article was originally published in The Gray Sheet

Executive Summary

Preparations for the U.S. launch of Novoste's Beta-Cath intracoronary radiation catheter system to treat in-stent restenosis are nearly complete, and the firm hopes to receive final FDA approval in time for the American Heart Association meeting in mid-November. The company reported receiving an "approvable" letter from the agency on Oct. 16.
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