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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 NameVISX EXCIMER LASER SYSTEM MODELS "B" AND "C"
Classification Nameexcimer laser system
Generic Nameeximer laser for ophthalmic use
ApplicantVISX, INCORPORATED
PMA NumberP930016
Supplement NumberS001
Date Received04/18/1996
Decision Date10/15/1996
Product Code
LZS[ Registered Establishments with LZS ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Labeling changes (i. E. , minor editoral changes to the patient information booklet, contrast sensitivity/glare precautionary statement in lieu of a postapproval contrast sensitivity study, and definitions of potential risks with prk).
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