Presumed safe no more: lessons from the Wingspan saga on regulation of devices.
Albert Einstein College of Medicine, Bronx, NY 10461, USA.
Ari J
AJ
Gartenberg
Ariel
A
Peleg
Sanket S
SS
Dhruva
Rita F
RF
Redberg
D001921:Brain / Q000098:blood supply*; D004869:Equipment Safety; D049674:History, 21st Century; D006801:Humans; D062307:Medical Device Legislation / Q000266:history; D015607:Stents / Q000009:adverse effects* / Q000592:standards; D020521:Stroke / Q000517:prevention & control; D014481:United States; D014486:United States Food and Drug Administration / Q000266:history