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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 EXCIMER LASER SYSTEM MODELS B AND C
Generic NameExcimer laser system
ApplicantAMO Manufacturing USA, LLC
510 Cottonwood Drive
Milpitas, CA 95035
PMA NumberP930016
Date Received06/15/1993
Decision Date03/27/1996
Product Code LZS 
Docket Number 97M-0084
Notice Date 03/25/1997
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE VISX EXCIMER LASER SYSTEM (MODELS B AND C)
Supplements: S035  S001 S002 S003 S004 S038 S043 S046 S047 S040 S042 
S045 S020 S021 S022 S006 S007 S017 S018 S013 S014 S015 S016 
S027 S011 S025 S026 S010 S048 S049 S008 S012 S005 S036 S044 
S023 S024 S019 S031 S032 S034 S028 S029 S030 S052 S050 S051 
S055 S059 S063 S054 S053 S056 S057 S058 S060 S061 S062 S064 
S066 
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