Synthes cervical disc “approvable”
This article was originally published in The Gray Sheet
Executive Summary
Swiss firm says Oct. 25 it has received an "approvable" letter from FDA for its ProDisc-C total cervical disc replacement. Final PMA approval is subject to a review of the firm's manufacturing processes. Medtronic's Prestige, approved in July, is the only artificial cervical disc on the U.S. market. An FDA advisory panel also recommended approval of Medtronic's Bryan cervical disc in July (1"The Gray Sheet" July 23, 2007, p. 3)