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This article was originally published in The Gray Sheet

Executive Summary

Firm preparing response to Feb. 7 questions by FDA on March 2000 PMA supplement for the LaserScan LSX for treatment of astigmatism using photorefractive keratectomy. In December, the firm filed a separate PMA supplement for LASIK treatment of myopia and myopic astigmatism

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Firm submits PMA supplement for use of its LaserScan LSX excimer laser in LASIK surgery to correct hyeropia of +0.5D to +8.0D and hyperopic astigmatism of up to +6.0D. LaserSight submitted a PMA supplement for LASIK treatment of myopia in December 2000. Approval of a March 2000 PMA supplement submission for treatment of astigmatism using photorefractive keratectomy has been delayed by questions raised by FDA (1"The Gray Sheet" Feb. 19, 2001, In Brief)

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