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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 NumberS004
Date Received12/17/1996
Decision Date06/12/1997
Product Code
LZS[ Registered Establishments with LZS ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for revised protocol for post-approval study to detect and report rare but serious adverse event. *please note that long-term data must be reflected in the labeling (via a supplement to the pma) when the additional follow-ups and/or post-approval studies are completed.
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