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FDA Orders Postmarket Surveillance Studies on Certain Spinal Systems
Date:10/5/2009

wing the clinical data gathered from the postmarket surveillance studies, the FDA will consider whether labeling changes or additional preclinical and clinical testing requirements are necessary for these devices.

Link to FDA's Web site on 522 Postmarket Surveillance Studies: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pss.cfm

Media Inquiries: Peper Long, 301-796-4671, mary.long@fda.hhs.gov

Consumer Inquiries: 1-888-INFO-FDA

SOURCE U.S. Food and Drug Administration


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SOURCE U.S. Food and Drug Administration
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