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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.
 
Trade NameINTACS PRESCRIPTION INSERTS
Classification Nameimplant, corneal, refractive
ApplicantADDITION TECHNOLOGY
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 - component
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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