VertiFlex Announces Submission Of Final PMA Module To The FDA, For The Superion® Interspinous Spacer System
4/1/2014 2:10:08 PM
SAN CLEMENTE, Calif.--(BUSINESS WIRE)--VertiFlex®, Inc., a leading innovator of advanced minimally invasive spinal surgery technologies, announces submission of the final module of the pre-market approval (PMA) application to the U.S. Food and Drug Administration (FDA) to support approval for the Superion® Interspinous Spacer System. The final module covers the clinical results from the Superion IDE trial evaluating the safety and effectiveness of the Superion Interspinous Spacer (Superion ISS) for the treatment of lumbar spinal stenosis.
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