April 16th, 2010

FDA Permits Boston Scientific to Resume Sales of Most ICDs

FDA Permits Boston Scientific to Resume Sales of Most ICDs: Following a 30-day suspension of sales of Boston Scientific ICDs and CRT-Ds, the FDA has given the company a green light to resume sales of most, but not all, of these devices. The suspension occurred after the company made significant manufacturing changes without following FDA approval procedures. Boston Scientific said sales of its current generation of devices, Cognis CRT-Ds and Teligen ICDs, would resume immediately. (Boston Scientific press release; New York Times story.)

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