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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameINTACS PRESCRIPTION INSERTS/INTACS CORNEAL IMPLANTS
Classification Nameimplant, corneal, refractive
ApplicantADDITION TECHNOLOGY
PMA NumberP980031
Date Received07/14/1998
Decision Date04/09/1999
Product Code
LQE[ Registered Establishments with LQE ]
Docket Number 99M-1167
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
This device is indicated for the reduction or elimination of mild myopia (-2. 00 to -3. 00 diopters spherical equivalent at the spectacle plane) in patients: who are 21 yrs of age or older; with documented stability of refraction as demonstrated by a change of less than or equal to 0. 50d for at least 12 months prior to the preoperative examination; and where the astigmatic components are +1. 00d or less.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S011 S012 
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