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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.
Classification Nameexcimer laser system
Generic Nameeximer laser for ophthalmic use
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.