A group of doctors convened by the Food and Drug Administration decided Tuesday that a new St. Jude Medical heart device to prevent strokes appears safe and effective, after more than 13 years of U.S. clinical research for the Minnesota-invented gadget.
By a 15-1 vote, the doctors on the panel said Tuesday that the long-running study showed a “reasonable assurance” that the Amplatzer PFO Occluder is safe for use. The same panel voted 11-5 that the device’s benefits outweigh its risks, and 9-7 that it is effective for its intended use.
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