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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 Nameexcimer laser system
AMO Manufacturing USA, LLC
510 cottonwood drive
milpitas, CA 95035
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/instructions/shelf life/tradename
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.