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Editor: Marc Jay Bern
Profession: Defective Medical Device Lawyer

Category: Medtronic News

An FDA advisory panel supports approval of Medtronic's Revo MRI SureScan Pacing System - the first pacemaker safe for use with MRIs.

On March 19, the Circulatory Systems Devices panel recommended suggested the following condtions for approval - the medical device maker would conduct a post-market study, provide training to providers and to create labeling that states MRI scans are to be conducted ONLY with the complete Revo System and NOT with other pacemakers as they are not approved for use.

Special hardware is included in the new Revo MRI device, which is designed to reduce or eliminate problems.