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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the Original HDE to get an up-to-date view of this device.
 
Trade NameINTACS® Corneal Implants
Classification Nameimplant, corneal, refractive
Generic Nameimplant, corneal, refractive
Applicant
Addition Technology
820 oak creek dr.
lombard, IL 60148
HDE NumberH040002
Supplement NumberS006
Date Received02/13/2024
Decision Date05/02/2025
Product Code
LQE[ Registered Establishments with LQE ]
Advisory Committee Ophthalmic
Supplement Typenormal 75 day track
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
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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