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Monday, November 5, 2018

Mazor Robotics granted 510(k) approval for Mazor X Stealth Edition


The Mazor X Stealth Edition was granted 510(k) premarket approval as “substantially equivalent” by the FDA on November 2, according to a post to the agency’s website. Medtronic (MDT) announced an agreement to acquire Mazor Robotics (MZOR) on September 20. The acquisition is expected to close during Medtronic’s third fiscal quarter ending January 25, 2019, subject to the satisfaction of customary closing conditions including receipt of regulatory clearances and approval by Mazor’s shareholders.

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