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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
Classification Nameexcimer laser system
Generic Nameexcimer laser system
6201 s freeway
ft worth, TX 76134
PMA NumberP970043
Supplement NumberS002
Date Received03/03/1999
Decision Date12/03/1999
Product Code
LZS[ Registered Establishments with LZS ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to modify the current labeling by 1)updating the clinical results with 12-month data; 2)presenting the 12-month data stratified into three groups (low myopia, low myopia with astigmatism, and high myopia with and without astigmatism) based on preoperative refractive error, and 3) including new contrast sensitivity claims based on a contrast sensitivity study of 284 pts. Other modifications to the labeling include editorial changes, the addition of new data tables reformatted to reflect the revised stratification of data, and the inclusion of a revised contrast sensitivity labeling statement to read: "In a constrast sensitivity study designed to assess theeffects of LADARVision surgery on how well patients can see in conditions such as very dim light, rain, snow, fog or glare from bright lights at night, the percentages of patients showing clinically significant losses were 10.6% at 6 months and 6.6% at 12 months after surgery, and the percentages of patients showing clinically significant improvements were 5.9% at 6 months and 3.3% at 12 months after surgery."