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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
Classification Nameartificial iris
Generic Nameartificial iris
Applicant
Clinical Research Consultants, Inc.
3308 jefferson avenue, upper level
cincinnati, OH 45220
PMA NumberP170039
Date Received11/29/2017
Decision Date05/30/2018
Product Code
QBT[ Registered Establishments with QBT ]
Advisory Committee Ophthalmic
Clinical Trials NCT01860612
Expedited Review Granted? No
Combination Product No
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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 
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