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Thoratec HeartMate

This article was originally published in The Gray Sheet

Executive Summary

Firm expects FDA to grant PMA supplement approval of the left-ventricular assist device as an alternative to transplant in the near future. "Based on our most recent discussions with the FDA" and upcoming labeling discussions, "we continue to have a great deal of confidence that we are close to receiving approval for destination therapy," President and CEO Keith Grossman reports during an Oct. 23 earnings call. Thoratec also expects a PMA supplement filing for the IVAD implantable ventricular assist device in the first half of 2003...

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