FDA advisory panel votes in favor of the Amplatzer PFO occluder device
By an 11 to 5 margin, an FDA advisory panel voted that the benefits of St. Jude Medical’s Amplatzer PFO occluder device outweighs its risks, the Minneapolis Star Tribune reports.
The same panel voted 15-1 in favor of the device’s safety and 9-7 in favor of its efficacy. If approved, the device could account for between $200 million and $350 million in sales, according to the newspaper.
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