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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)

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Cervical disc approval

Synthes plans surgeon training and a controlled roll-out in January for its ProDisc-C implant to treat cervical disc degeneration. The device received FDA approval Dec. 18 following the completion of a review of the manufacturing processes. Synthes had received an approvable letter from FDA in October 2007 after clinical review of the disc (1"The Gray Sheet" Oct. 29, 2007, In Brief). Medtronic's Prestige, approved in July, is the only other artificial cervical disc on the U.S. market; an FDA advisory panel also recommended approval of Medtronic's Bryan cervical disc in July

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