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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 PRESCRIPTION INSERTS FOR KERATOCONUS
Classification Nameimplant, corneal, refractive
Generic Nameimplant, corneal, refractive
Applicant
ADDITION TECHNOLOGY
820 oak creek drive
lombard, IL 60148
HDE NumberH040002
Supplement NumberS001
Date Received11/16/2006
Decision Date03/23/2010
Product Code
LQE[ Registered Establishments with LQE ]
Advisory Committee Ophthalmic
Supplement Typenormal 75 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval of the 0. 21rim, 0. 40mm and 0. 45mm intacs® prescription inserts for the treatment of keratoconus.
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