LaserSight
This article was originally published in The Gray Sheet
Executive Summary
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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LaserSight
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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