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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.
 
DeviceArtisan Myopia
Generic NameLens, intraocular, phakic
ApplicantOPHTEC BV
Schweitzerlaan 15
Groningen 9728
PMA NumberP030028
Supplement NumberS009
Date Received02/08/2022
Decision Date07/22/2022
Product Code MTA 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Change to the processing agent used in the milling process for the ARTISAN Myopia.
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