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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.
 
DevicePreVue Preloaded IOL System
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantHOYA SURGICAL OPTICS, INC.
14768 PIPELINE AVENUE
CHINO HILLS, CA 91709
PMA NumberP080004
Supplement NumberS035
Date Received08/07/2020
Decision Date11/03/2020
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the PreVue Preloaded IOL System Model PreVue Y and to rename the Clarisert Preloaded IOL System Model CLSRT to the PreVue Preloaded IOL System Model PreVue C.
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