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. |
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Device | KAMRA INLAY |
Generic Name | Implant, corneal, refractive |
Applicant | CorneaGen 1200 6th Avenue Suite 300 Seattle, WA 98101 |
PMA Number | P120023 |
Supplement Number | S002 |
Date Received | 10/28/2015 |
Decision Date | 10/07/2016 |
Withdrawal Date
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02/03/2022 |
Product Code |
LQE |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
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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