Downclassification of temporary mandibular condyle implants sought by Pfizer.
This article was originally published in The Gray Sheet
Executive SummaryMANDIBULAR CONDYLE TEMPORARY IMPLANT DOWNCLASSIFICATION SOUGHT BY PFIZER in a petition to FDA. The company argues that the devices pose less of a risk than permanent implants used to treat temporomandibular joint disorder because they usually remain in the patient only 6-12 months and have reduced load-bearing requirements compared to TMJ implants. The titanium temporary mandibular condyle implants sold by Pfizer's Howmedica Leibinger business are components of its Dynamic Bridging, Locking Screw, Luhr, Marx, 1st Generation Wurzburg, and 2nd Generation Wurzburg mandibular reconstruction systems.
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