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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameLADARVISION EXCIMER LASER SYSTEM
Classification Nameexcimer laser system
Generic Nameophthalmic excimer laser system
ApplicantALCON LABORATORIES, INC.
PMA NumberP970043
Supplement NumberS001
Date Received01/28/1999
Decision Date09/24/1999
Product Code
LZS[ Registered Establishments with LZS ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the inclusion of labeling claims in the patient information booklet, physician's booklet, and system operation manual regarding the effectiveness of the eye tracker component of the ladarvision(r) excimer laser system when used for the approved indication. Other requested modifications to the labeling included updates to data tables in the physician's booklet, and editorial changes and revised operational procedures in the system operation manual.
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