MEMPHIS, Tenn. – July 17, 2007 – Medtronic, Inc. (NYSE: MDT) today announced the Bryan® Cervical Disc has received a recommendation for approval from the U.S. Food and Drug Administration’s (FDA) Orthopedic and Rehabilitation Devices adviso
ry panel.
The panel recommended a variety of conditions that will be considered by the FDA during its ongoing review process.
The panel’s decision was based in part on a successfully conducted prospective, randomized controlled clinical trial that showed substantial improvements in several major outcome measures of the study. The panel’s recommendation will next be considered by the FDA in its review of the Premarket Approval (PMA) application for the implant. Upon final FDA approval of the PMA application, the Bryan Cervical Disc will be available to patients in the United States.
Medtronic Receives FDA Panel's Recommendation for Approval of The Bryan® Cervical Disc
Hat Tip: Medgadget
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