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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 EXCIMER LASER SYSTEM
Generic Nameexcimer laser system
ApplicantAMO Manufacturing USA, LLC
510 cottonwood drive
milpitas, CA 95035
PMA NumberP930016
Supplement NumberS046
Date Received10/19/2015
Decision Date01/11/2016
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 CHANGES TO THE FRONT PANEL ASSEMBLY OF THE STAR S4 IR SYSTEM WITH RELATED CHANGES AND MINOR UPDATES TO THE STAR S4 IR OPERATORS MANUAL.
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