The Boston Scientific Corporation on Thursday announced that the Food and Drug Administration had permitted it to resume defibrillator sales after a one-month halt due to the company's failure to notify regulators related to manufacturing changes to the devices.
The F. D. A.'s decision eradicated the uncertainty that had besieged Boston Scientific since it suspended defibrillator sales in the United States last month.
Boston Scientific and F. D. A. officials reveal that the variations were not linked to the safety of the devices.
However, industry analysts had posted that any long delay in calming the issue could result in a significant loss of market share for the company.
"We are very pleased that the F. D. A. has cleared the manufacturing changes," Ray Elliott, the company's president and chief executive, said Thursday in a statement. "We are committed to doing the right thing every time."
Sales of devices as defibrillator and a pacemaker mark a yield of $1.25 billion in revenue last year, about 15 percent of Boston Scientific's total revenue of $8.2 billion.
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