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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.
 
DeviceClareon Aspheric UV Absorbing IOL, Clareon Aspheric UV Absorbing IOL with the AutonoMe Automated Preloaded Delivery Devi
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantAlcon Laboratories, LLC
6201 S. Fwy.
Fort Worth, TX 76134
PMA NumberP190018
Supplement NumberS003
Date Received04/30/2020
Decision Date07/20/2020
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for Clareon Aspheric UV Absorbing intraocular lens (IOL) Model CC60WF and Clareon Aspheric UV Absorbing IOL with the AutonoMe Automated Preloaded Delivery Device Model CCA0T0.
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