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TRIMEDYNE TO SUBMIT ADDITIONAL UROLASE PMA DATA IN "EARLY '95,"

This article was originally published in The Gray Sheet

Executive Summary

TRIMEDYNE TO SUBMIT ADDITIONAL UROLASE PMA DATA IN "EARLY '95," the company said in a release. Review of the company's premarket approval application for use of the side-firing laser for the treatment of benign prostatic hyperplasia was delayed by FDA's request for "further clarification and analysis" of data in March of this year ("The Gray Sheet" March 28, In Brief). The device was cleared by FDA in July for general urological use and currently is being sold by Bard for that indication.
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