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Medical Devices / Submissions and Approvals

FDA Approves MRI-Conditional Labeling on Two Abbott Defibrillators

Jan. 8, 2018

The FDA approved Abbott’s MRI-conditional labeling for two of its defibrillator devices.

The new labeling on the Quadra Assura MP Cardiac Resynchronization Therapy Defibrillator, and its Fortify Assura Implantable Cardioverter Defibrillator will aid in clinical assessments. 

The ICDs are intended for restoring normal heart rhythms, whereas CRT-D implant devices are designed to assist the lower chambers of hearts and improve blood flow throughout the bodies of patients with progressive congestive heart failure. 

MRI-conditional labeling was approved in October 2017 on the company’s Ellipse ICD, which is indicated to monitor heart rhythms to deliver treatment shocks to the heart when necessary.

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