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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.
 
DeviceLADAR VISION 4000 EXCIMER LASER SYSTEM
Generic NameExcimer laser system
ApplicantALCON LABORATORIES
6201 S FREEWAY
FT WORTH, TX 76134
PMA NumberP970043
Supplement NumberS016
Date Received11/10/2003
Decision Date02/09/2004
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 NEW LASER ASSEMBLY SYSTEM TO REPLACE THE EXISTING ASSEMBLY IN THE APPROVED LADARVISION 4000 EXCIMER LASER SYSTEM.
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