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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameSVS APEX APEX EXIMER LASER WORKSTATION
Classification Nameexcimer laser system
ApplicantSUMMIT TECHNOLOGY, INC.
PMA NumberP930034
Supplement NumberS003
Date Received03/12/1996
Decision Date11/25/1996
Product Code
LZS[ Registered Establishments with LZS ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
All labeling must contain the following precaution statement: precaution: although the effects of prk on visual performance under poor lighting conditions have not been determined, it is possible that you will find it more difficult than usual to see in conditions such as very dim light, rain, snow, fog, or glare from bright lights at night.
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