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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 Intraocular Lens
Generic NameLens, intraocular, phakic
ApplicantOphtec BV
Schweitzerlaan 15
Groningen 9728 NR
PMA NumberP030028
Supplement NumberS008
Date Received02/06/2019
Decision Date05/14/2019
Product Code MTA 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for minor labeling changes for the Physician’s Labeling and Patient Brochure.
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