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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 NumberS003
Date Received08/26/1996
Decision Date04/24/1997
Product Code
LZS[ Registered Establishments with LZS ]
Docket Number 97M-0084
Notice Date 04/17/1998
Advisory Committee Ophthalmic
Supplement Typepanel track
Supplement Reason labeling change - indications
Expedited Review Granted? Yes
Combination Product No
Approval Order Statement 
Approval for the visx excimer laser system (models b & c). This device is indicated for myopic astigmatic photorefractive keratectomy (prka) using an ablation zone with a 6. 0 mm major axis.
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