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

"U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx> · Fri, 28 Oct 2016 13:05:53 -0500

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

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News Release

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

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.
Read more.
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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