PMA P120023S002

Device: KAMRA INLAY
Applicant: Corneagen
PMA number: P120023
Supplement: S002
Product code: LQE
Decision date: 2016-10-07
Generic name: Implant, corneal, refractive
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.

Current openFDA PMA Record#

Device: KAMRA INLAY
Applicant: Corneagen
PMA number: P120023
Supplement: S002
Product code: LQE
Generic name: Implant, corneal, refractive
Decision date: 2016-10-07
Decision code: APPR
Date received: 2015-10-28
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
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.