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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.
 
DeviceKAMRA INLAY
Generic NameImplant, corneal, refractive
ApplicantCorneagen
1200 6th Ave.
Suite 300
Seattle, WA 98101
PMA NumberP120023
Supplement NumberS004
Date Received09/28/2016
Decision Date05/16/2017
Withdrawal Date02/03/2022
Product Code LQE 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol - OSB
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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