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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 Models 204US1W and 206US1W
Generic NameLens, intraocular, phakic
ApplicantOphtec BV
Schweitzerlaan 15
Groningen 9728 NR
PMA NumberP030028
Supplement NumberS013
Date Received11/12/2025
Decision Date04/24/2026
Product Code MTA 
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  
the addition of an alternative third-party testing laboratory for routine bioburden and endotoxin quality control testing
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