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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceCustomFlex Artificial Iris
Generic NameArtificial iris
ApplicantHumanOptics AG
Spardorfer Strasse 150
Erlangen 91054
PMA NumberP170039
Date Received11/29/2017
Decision Date05/30/2018
Product Code QBT 
Advisory Committee Ophthalmic
Clinical TrialsNCT01860612
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the CustomFlex Artificial Iris. The CustomFlex Artificial Iris is indicated for use in children and adults for the treatment of full or partial aniridia resulting from congenital aniridia, acquired defects, or other conditions associated with full or partial aniridia.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002  S003 
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