FDAnews
www.fdanews.com/articles/176190-fda-panel-to-review-st-judes-amplatzer-cardiac-implant

FDA Panel to Review St. Jude’s Amplatzer Cardiac Implant

April 13, 2016

The Circulatory System Devices Panel of the Medical Devices Committee will meet May 24 to review the premarket approval application for St. Jude Medical’s Amplatzer Patent Foramen Ovale Occluder, according to a Federal Register notice.

The permanent cardiac implant is intended to prevent ischemic stroke in patients who have had cryptogenic stroke related to a paradoxical embolism.

Read the notice here: www.fdanews.com/04-13-16-CirculatoryAdComm.pdf — Anisa Jibrell