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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 NumberS002
Date Received10/28/2015
Decision Date10/07/2016
Withdrawal Date02/03/2022
Product Code LQE 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of incorporation of a new double tray packaging configuration in order to accommodate physicians' ease of use. The new packaging configuration has currently been validated for a 5-year shelf life. In addition, an alternate sterilization site, Sterigenics US LLC, has been validated for the proposed packaging.
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