Cervical disc approval
This article was originally published in The Gray Sheet
Executive Summary
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
You may also be interested in...
Synthes cervical disc “approvable”
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)
Abbott's ‘Bedrock Of Good Health’ Nutritionals Business Faces Mounting Infant Formula Litigation
Nutritional product business had 5.1% Q1 sales growth and is like Abbott’s other segments, “super well-aligned to the global demographics and trends in health care,” says CEO Ford. But as it defends complaints of damages from powder formulas made at facility found with unsafe levels of bacterial contaminants, Abbott’s also targeted in litigation alleging failure to warn about risk of infants born prematurely developing necrotizing enterocolitis if fed cow’s milk-based formula.
‘Core Pillars’ Of Safety And Innovation Take Center Stage In FDA Reports
The US FDA has issued a pair of reports focused on device safety and innovation. The reports describe recent steps the agency has taken to improve in the two areas, and what it plans to do next.