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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 Phakic lntraocular Lens (IOL),
Generic NameLens, intraocular, phakic
ApplicantOphtec BV
Schweitzerlaan 15
Groningen 9728 NR
PMA NumberP030028
Supplement NumberS012
Date Received12/21/2023
Decision Date01/18/2024
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  
a change to the supplier of the packaging Tyvek lid
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