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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Classification Nameimplant, corneal, refractive
PMA NumberP120023
Date Received12/12/2012
Decision Date04/17/2015
Product Code
LQE[ Registered Establishments with LQE ]
Docket Number 15M-1326
Notice Date 04/29/2015
Advisory Committee Ophthalmic
Clinical Trials NCT00819299
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the kamra inlay. The kamra inlay is indicated for intrastromal corneal implantation to improve near vision by extending the depth of focus in the non-dominant eye of phakic, presbyopic patients between the ages of 45 and 60 years old who have cycloplegic refractive spherical equivalent of +0. 50 d to -0. 75 d with less than or equal to 0. 75 d of refractive cylinder, who do not require glasses or contact lenses for clear distance vision, and who require near correction of +1. 00 d to +2. 50 d of reading add.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress