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Abiomed seeks HDE approval

This article was originally published in The Gray Sheet

Executive Summary

Danvers, Mass. firm submits humanitarian device exemption application for its AbioCor implantable replacement heart Sept. 1 and anticipates HDE approval by the end of its fiscal year in March 2005 (1"The Gray Sheet" April 19, 2004, p. 23). Abiomed has enrolled 14 of 15 patients for its clinical trial, the firm also notes Sept. 8...

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