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Lumenis Gynelase/ELITT

This article was originally published in The Gray Sheet

Executive Summary

Israeli firm elects to stop clinical trials of laser system for the treatment of excessive menstrual bleeding following the release of interim results that would not be sufficient to support an FDA marketing claim, Lumenis announces April 4. The company is currently working with FDA to modify the trial. A PMA submission was originally planned for the end of 2002, and the extent of the delay is still under evaluation...

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