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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.
 
DeviceSingle-Piece PMMA Posterior Chamber IOL
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantAlcon Laboratories
6201 S. Fwy.
Fort Worth, TX 76134
PMA NumberP840060
Supplement NumberS049
Date Received06/21/2021
Decision Date12/02/2021
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 PT. CIBA VISION Batam located at Jalan Beringin Kav. #204, Batamindo Industrial Park, Muka Kuning Batam Island, 29433 Indonesia for manufacturing, packaging, and sterilization.
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