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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/EVO+ VISIAN® Implantable Collamer® Lenses
Generic NameLens, intraocular, phakic
ApplicantSTAAR Surgical Company
1911 WALKER AVE.
MONROVIA, CA 91016
PMA NumberP030016
Supplement NumberS043
Date Received04/04/2022
Decision Date05/04/2022
Product Code MTA 
Advisory Committee Ophthalmic
Clinical TrialsNCT04283149
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval of the protocol for the post-approval study (PAS) protocol.
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