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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.
 
DeviceINTACS® Corneal Implants
Generic NameImplant, corneal, refractive
ApplicantAddition Technology
820 Oak Creek Dr.
Lombard, IL 60148
PMA NumberP980031
Supplement NumberS014
Date Received02/09/2024
Decision Date05/02/2025
Product Code LQE 
Advisory Committee Ophthalmic
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
changes to the polishing and cleaning processes; changes to the supplier of Poly(methyl methacrylate) (PMMA) and Tyvek; and changes to the limulus amebocyte lysate (LAL) testing.
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