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Panel to Discuss St. Jude Medical PMA for Stroke Patients

04/13/2016

Federal Register Notice: FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee will meet 5/24, from 8 a.m. to 6 p.m. at the Hilton Washington DC North/Gaithersburg, Salons A, B, C and D, 620 Perry Pkwy., Gaithersburg, MD. The committee will discuss, make recommendations and vote on information related to the premarket approval application regarding St. Jude Medical’s Amplatzer Patent Foramen Ovale (PFO) Occluder. It is a percutaneously delivered permanent cardiac implant for PFO closure indicated for preventing recurrent ischemic stroke in patients who have had a cryptogenic stroke due to a presumed paradoxical embolism. Contact Evella Washington, Evella.Washington@fda.hhs.gov, (301) 796-6683. To view this notice, click here.

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