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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.
 
DeviceTECHNOLAS EXCIMER LASER SYSTEM (217A AND 217Z)
Generic NameExcimer laser system
ApplicantTechnolas Perfect Vision GmbH
Messerschmittstr. 1+ 3
München 80992
PMA NumberP990027
Supplement NumberS022
Date Received08/13/2024
Decision Date11/06/2024
Product Code LZS 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for the replacement of the operation microscope and magnification changer used in the Technolas Excimer Laser System (217a and 217z).
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