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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCustomFlex Artificial Iris
Generic NameArtificial iris
ApplicantHumanoptics AG
Spardorfer Strasse 150
Erlangen 91054
PMA NumberP170039
Supplement NumberS002
Date Received07/19/2018
Decision Date10/03/2019
Product Code QBT 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of the protocol for the post-approval study (PAS) protocol.
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