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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.
 
DeviceLADARVISION EXCIMER LASER SYSTEM
Generic NameExcimer laser system
ApplicantAlcon Laboratories
6201 S. Fwy.
Fort Worth, TX 76134
PMA NumberP970043
Supplement NumberS005
Date Received09/03/1999
Decision Date05/09/2000
Withdrawal Date05/15/2012
Product Code LZS 
Docket Number 00M-1593
Notice Date 11/14/2000
Advisory Committee Ophthalmic
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the LADARVision Excimer Laser System indicated for laser in-situ keratomileusis (LASIK).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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