The Food and Drug Association (FDA) issued a Humanitarian Device Exemption (HDE) approval order for the AMPLATZERTM PIVSD Occluder on January 10, 2017. The Conditions of Approval require that St. Jude Medical (SJM) conduct a post approval study to evaluate the safety and probable benefit of the AMPLATZERTM PIVSD Occluder.
Thank you for your interest, but this study is recruiting by invitation only.
North Carolina (Statewide)
Medicine - Cardiology
Clinical or Medical
Heart and Circulation