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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 drive
lombard, IL 60148
HDE NumberH040002
Supplement NumberS005
Date Received02/01/2024
Decision Date09/09/2024
Product Code
LQE[ Registered Establishments with LQE ]
Advisory Committee Ophthalmic
Supplement Typenormal 75 day track
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
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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