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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, S41R EXCIMER LASER SYSTEM
Generic NameExcimer laser system
ApplicantAmo Manufacturing USA, LLC
510 Cottonwood Dr.
Milpitas, CA 95035
PMA NumberP990010
Supplement NumberS004
Date Received05/01/2014
Decision Date05/30/2014
Product Code LZS 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE OF THE FRAME GRABBER PRINTED CIRCUIT BOARD (PCB) OF THE STAR SYSTEM.
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