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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.
 
DeviceSVS APEX APEX EXIMER LASER WORKSTATION
Generic NameExcimer laser system
ApplicantAlcon Laboratories, Inc.
2501 DISCOVERY DRIVE,SUITE 500
ORLANDO, FL 32826-3714
PMA NumberP930034
Supplement NumberS003
Date Received03/12/1996
Decision Date11/25/1996
Withdrawal Date 05/18/2010
Product Code LZS 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Other
Expedited Review Granted? No
Combination ProductNo
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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