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This article was originally published in The Gray Sheet
WorldHeart will supply FDA with more data and statistical analysis on patient demographics and adverse events from the INTrEPID trial of the Novacor left-ventricular assist device to support its PMA supplement for a destination therapy indication, the company announced March 25. The PMA supplement was accepted by the Office of Device Evaluation Nov. 22 (1"The Gray Sheet" Nov. 25, 2002, In Brief)...
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