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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.
 
DeviceIPure Preloaded IOL System
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantHOYA SURGICAL OPTICS, INC.
14768 PIPELINE AVENUE
CHINO HILLS, CA 91709
PMA NumberP080004
Supplement NumberS030
Date Received12/16/2019
Decision Date04/17/2020
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for packaging changes for the iSert® Preloaded System Platform Models 250 and 251. This device, as modified, will be marketed under the tradename IPure Preloaded System Platform Models B1PC and B1PY and is indicated for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed.
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