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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 EXCIMER LASER SYSTEM
Classification Nameexcimer laser system
Generic Nameexcimer laser system
Applicant
ALCON LABORATORIES
6201 s freeway
ft worth, TX 76134
PMA NumberP970043
Supplement NumberS003
Date Received04/16/1999
Decision Date05/12/1999
Product Code
LZS[ Registered Establishments with LZS ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for labeling changes (i.e., minor editorial changes and the addition of a precaution statement to the Patient Information Booklet, Physicians' Booklet, and System Operation Manual. The System Operation Manual also included some revised instructions for use, including directions to follow in the event of a power interruption before or during treatment).
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