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Interventional cardiology / Kurt Amplatz / Radiologists / Atrial septal defect / Pharmacology / Food and Drug Administration / Center for Devices and Radiological Health / Cardiology / Medical device / Medicine / Health / Congenital heart disease


DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration[removed]New Hampshire Ave. Silver Spring MD 20993
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Company

Cleveland Clinic / W. L. Gore & Associates / Special Medical Programs / J.D. Associate / /

Country

United States / /

Currency

USD / /

Event

FDA Phase / Person Communication and Meetings / /

Facility

Cleveland Clinic Lerner College of Medicine / Clinic Foundation / /

IndustryTerm

marketed and investigational devices / literature search / clinical site / treatment of an important congenital heart disease / /

MedicalCondition

atrial septal defects / disease / congenital cardiovascular disease / transcatheter Atrial Septal Defect / structural heart disease / important congenital heart disease / atrial septal defect / /

MedicalTreatment

catheterization / surgical treatment / /

Organization

Circulatory System Devices Panel / Tolino /S/ Director / Ethics and Integrity Staff office of Management Michael F. Ortwerth / National Institute of Health / OMO Center for Devices and Radiological Health Name of Advisory Committee Member / Case Western Reserve University School of Medicine / Food and Drug Administration / Medical Devices Advisory Committee / Management Staff Office / Cleveland Clinic Lerner College of Medicine / Cleveland Clinic Foundation / Center for Drug Evaluation and Research / DEPARTMENT OF HEALTH / Conference Management Branch Division of Ethics and Management Operations / /

Person

Michael F. Ortwerth / Kathleen L. Walker / Jill Hartzler Warner / Kenneth G. Zahka / Vince Tolino / /

Position

MEd.___________ /S/_____________________ Chief / Professor of Pediatrics / Staff Cardiologist / Commissioner / pediatric cardiologist / representative / /S/ Director / /

Product

Helex® Septal Occluder / GORE® HELEX / /

SocialTag