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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
Classification Nameexcimer laser system
Generic Nameexcimer laser system
Applicant
AMO Manufacturing USA, LLC
510 cottonwood drive
milpitas, CA 95035
PMA NumberP930016
Date Received06/15/1993
Decision Date03/27/1996
Product Code
LZS[ Registered Establishments with LZS ]
Docket Number 97M-0084
Notice Date 03/25/1997
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
APPROVAL FOR THE VISX EXCIMER LASER SYSTEM (MODELS B AND C)
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S010 
S011 S012 S013 S014 S015 S016 S017 S018 S019 
S020 S021 S022 S023 S024 S025 S026 S027 S028 
S029 S030 S031 S032 S034 S035 S036 S038 S040 
S042 S043 S044 S045 S046 S047 S048 S049 S050 
S051 S052 S053 S054 S055 S056 S058 S059 
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