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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.
 
DeviceiSert Preloaded System
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantHoya Surgical Optics, Inc.
14768 Pipeline Ave.
Chino Hills, CA 91709
PMA NumberP080004
Supplement NumberS031
Date Received01/30/2020
Decision Date05/21/2021
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a manufacturing site located at HOYA Lamphun Ltd., 725 Moo 4, Tambol Banklang, Amphur Muagn, Lamphun 5100, Thailand. HOYA Lamphun Ltd. processes will be limited to machining, polishing, inspecting, assembly, and primary packaging (pre-sterilization) of intraocular lenses (IOLs) and injector cartridges.
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