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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.
 
DeviceVISIAN ICL (IMPLANTABLE COLLAMER LENS)
Generic NameLens, intraocular, phakic
ApplicantSTAAR Surgical Company
1911 Walker Ave.
Monrovia, CA 91016
PMA NumberP030016
Supplement NumberS048
Date Received02/14/2025
Decision Date11/14/2025
Product Code MTA 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
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 expanding the indicated age range from 21-45 years old to 21-60 years old for the EVO/EVO+ ICL/TICL.
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