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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceVISX STAR S4 ACTIVETRAK EXCIMER LASER SYSTEM
Generic NameExcimer laser system
ApplicantAMO Manufacturing USA, LLC
510 Cottonwood Drive
Milpitas, CA 95035
PMA NumberP930016
Supplement NumberS015
Date Received07/30/2002
Decision Date08/07/2002
Product Code LZS 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF AN AUTO-CENTERING FUNCTION TO THE VISX STAR S4 ACTIVE TRAK EYE TRACKING SYSTEM THAT INCLUDES MINOR DESIGN AND LABELING CHANGES.
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