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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.
 
DeviceSTAR S4 ACTIVETRAK EXCIMER LASER SYSTEM AND WAVESCAN WAVEFRONT SYSTEM
Generic NameExcimer laser system
ApplicantAMO Manufacturing USA, LLC
510 Cottonwood Drive
Milpitas, CA 95035
PMA NumberP930016
Supplement NumberS018
Date Received12/15/2003
Decision Date06/07/2004
Product Code LZS 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR SOFTWARE UPGRADE: WAVESCAN SOFTWARE VERSION 3.5 CHANGES FROM CURRENTLY APPROVED VERSION 3.07 (UNDER P930016/S016) FOR VISX STAR S4 ACTIVETRAK EXCIMER LASER SYSTEM FOR WAVEFRONT-GUIDED LASIK TREATMENTS OF MYOPIC ASTIGMATISM UP TO -6.00 D MRSE, WITH CYLINDER BETWEEN 0.00 AND -3.00 D.
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