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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceVISX MODELB/MODEL C EXCIMER LASER SYSTEM
Classification Nameexcimer laser system
Generic Nameexcimer laser system
Applicant
AMO Manufacturing USA, LLC
510 cottonwood drive
milpitas, CA 95035
PMA NumberP910062
Date Received10/16/1991
Decision Date09/29/1995
Product Code
LZS[ Registered Establishments with LZS ]
Docket Number 96M-0486
Notice Date 12/23/1996
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR VISX EXCIMER LASER SYSTEM (MODELS B & C)
Supplements: S001 S004 S006 S007 
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