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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.
 
DeviceAcrySoft Intraocular Lenses
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantALCON LABORATORIES, INC.
6201 SOUTH FREEWAY DR.
FORT WORTH, TX 76134
PMA NumberP930014
Supplement NumberS125
Date Received07/22/2019
Decision Date08/19/2019
Product Code HQL 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Use of coating solutions prepared at the manufacturing facility in West Virginia in the manufacture of UltraSert and AcrySert nozzle components.
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