TMJ Implants, Inc.' s Fossa-Eminence Not Approvable - FDA Dental Panel
This article was originally published in The Gray Sheet
Executive Summary
Members of FDA's Dental Products Panel questioned the adequacy of safety and efficacy data supporting use of TMJ Implants' Fossa-Eminence prosthesis for partial reconstruction of the temporomandibular joint as a first-line therapy, in recommending against FDA approval of the device Oct. 6 in Rockville, Maryland.
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