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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 (ICL)
Generic NameLens, intraocular, phakic
ApplicantSTAAR Surgical Company
1911 Walker Ave.
Monrovia, CA 91016
PMA NumberP030016
Supplement NumberS037
Date Received04/22/2019
Decision Date07/19/2019
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
RecallsCDRH Recalls
Approval Order Statement  
Approval to modify the labeling to include the lioli-24 IOL Delivery System to the current list of recommended delivery systems included in the Directions for Use (DFU) for the NanoFLEX® One-Piece Collamer Intraocular Lens (CIOL), Model CC4204A, and the sphere and toric Visian® ICL Implantable Collamer Lenses (MICL/TMICL).
Post-Approval StudyShow Report Schedule and Study Progress
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