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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
Generic Nameexcimer laser system
ApplicantAMO Manufacturing USA, LLC
510 cottonwood drive
milpitas, CA 95035
PMA NumberP930016
Supplement NumberS052
Date Received06/12/2017
Decision Date06/23/2017
Product Code LZS 
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Changes to the acceptance criteria and the supplier of the beam splitter used in the STAR S4 IR Excimer Laser System.
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