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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 PRESCRIPTION INSERTS/INTACS CORNEAL IMPLANTS
Generic NameImplant, corneal, refractive
ApplicantAddition Technology
820 Oak Creek Dr.
Lombard, IL 60148
PMA NumberP980031
Supplement NumberS013
Date Received10/02/2023
Decision Date09/09/2024
Product Code LQE 
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 AJL Ophthalmic, S.A., Ferdinand Zeppelin 1, Parque Tecnologico Alava, 01510 Minano, Araba, Spain, for manufacturing segment components, inspection, cleaning and primary packaging and sterilization of INTACS Corneal Implants
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