2007•SAS JournalRequires access

The First 18 Months Following Food and Drug Administration Approval of Lumbar Total Disc Replacement in the United States: Reported Adverse Events Outside an Investigational Device Exemption Study Environment

Scott L. Blumenthal, Richard D. Guyer, Fred Harden Geisler, Paul C. McAfee, John J. Regan

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Key concepts: Investigational device exemption, Food and drug administration, Medicine, Adverse effect, Lumbar, Drug approval, Drug, Surgery

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