FDA approves new device for prevention of recurrent strokes in certain patients

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For Immediate Release: October 28, 2016
Media Inquiries: Deborah Kotz, 301-796-5349, deborah.kotz@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

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FDA approves new device for prevention of recurrent strokes in certain patients

The U.S. Food and Drug Administration today approved the Amplatzer PFO Occluder device. The PFO Occluder reduces the risk of a stroke in patients who previously had a stroke believed to be caused by a blood clot that passed through a small hole in the heart, called a patent foramen ovale (PFO), and then traveled to the brain.

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