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DevicePMAs@therightstef:P060025_S010 JSONTXT

Approval for changes to the rinsing and fixations solutions used inthe manufacture of the device. the device, as modified, will be marketed under the trade name 3f aortic bioprosthesis, model 1000 and is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves.

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