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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.
 
DeviceEVO Visian Implantable Collamer Lens for Myopia (VICMO), EVO Visian Toric Implantable Collamer Lens for Myopia (VTICMO),
Generic NameLens, intraocular, phakic
ApplicantSTAAR Surgical Company
1911 Walker Ave.
Monrovia, CA 91016
PMA NumberP030016
Supplement NumberS047
Date Received09/10/2024
Decision Date03/05/2025
Product Code MTA 
Advisory Committee Ophthalmic
Clinical TrialsNCT04283149
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for modification to the labeling for the EVO/EVO+ VISIAN® Implantable CollamerTM Lens for Myopia and EVO/EVO+ VISIAN® TORIC Implantable CollamerTM Lens for Myopia to reflect the findings of the P030016/S035 PMA cohort follow-up Post-approval Study.
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