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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.
 
DeviceALCON LADARVISION 4000 EXCIMER LASER SYSTEM-
Generic NameExcimer laser system
ApplicantALCON LABORATORIES
6201 S FREEWAY
FT WORTH, TX 76134
PMA NumberP970043
Supplement NumberS021
Date Received09/26/2005
Decision Date10/14/2005
Withdrawal Date 05/15/2012
Product Code LZS 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A SOFTWARE CALIBRATION "LOCK-OUT" FEATURE WHERBY THE LASER SYSTEM WILL BE "LOCKED-OUT" TO PREVENT THE INITIATION OF SURGERY MORE THAN 60 MINUTES AFTER THE LAST SYSTEM CALIBRATION, A "COUNTDOWN CLOCK" ON THE COMPUTER MONITOR WHICH WILL PROVIDE THE USER WITH FEEDBACK ON THE REMAINING TIME BEFORE THE SYSTEM WILL LOCK-OUT, AND A SOFTWARE BUG FIX TO CORRECT A CERTAIN "BUG" FROM OCCURRING UNDER CERTAIN CONDITIONS IF THE RULER TOOL WAS USED WITH THE TRACKER ENGAGED DURING SURGERY.
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