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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceINTACS PRESCRIPTION INSERTS
Classification Nameimplant, corneal, refractive
Generic Nameimplant, corneal, refractive
Applicant
ADDITION TECHNOLOGY
820 oak creek drive
lombard, IL 60148
PMA NumberP980031
Supplement NumberS004
Date Received02/23/2000
Decision Date10/11/2001
Product Code
LQE[ Registered Establishments with LQE ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for 0. 275 mm and 0. 325 mm intacs(tm) as well as for a new trade name, "intacs(tm) prescription inserts. ".
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