Life-Saving, Smart Regulation on Behalf of Patients with Aortic Stenosis | FDA Voice: "Edwards Lifesciences presented us with an appropriate variance plan for addressing its manufacturing problems—including specific controls to permit safe use of the Sapien XT while corrections are underway.
We are committed to flexible, smart regulation, and to working with companies and the clinical community to ensure that innovative new medical devices that demonstrate a reasonable assurance of safety and effectiveness are available for patients in a timely manner."
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