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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.
 
DeviceAcrySof™ IOL Sterile UV-Absorbing Acrylic, Foldable Multipiece Posterior Chamber, Lenses, AcrySof™ Natural UV and Blue L
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantAlcon Laboratories, Inc.
6201 S. Fwy. Dr.
Fort Worth, TX 76134
PMA NumberP930014
Supplement NumberS141
Date Received11/29/2021
Decision Date11/02/2022
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: PT. Ciba Vision Batam Jalan Beringin Lot #204 Batamindo Industrial Park, Mukakuning, Batam Island 29433, Indonesia.
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