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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 IR Excimer Laser System, WaveScan WaveFront System, and iDesign Advanced WaveScan Studio System
Generic NameExcimer laser system
ApplicantAMO Manufacturing USA, LLC
510 Cottonwood Drive
Milpitas, CA 95035
PMA NumberP930016
Supplement NumberS056
Date Received12/31/2018
Decision Date04/12/2019
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 four edits in engineering drawing of "Beam Splitter, Energy Detector'' and change of the material in the Beam Splitter component of the Energy Detector from Corning Fused Silica Code 7940 to Corning 7980 HPFS.
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