Premarket Notification Application K963904 Heart Alert Inc. / HeartCard Cardiac Event Recorder / the Washington Post / NASPE / Instromedix / PaceArt Inc. / North American Society / Heart Alert Inc. / M.D. CONSUMER / M.D. INDUSTRY / /
Country
United States / /
Event
Reorganization / FDA Phase / /
Facility
Virginia Commonwealth University / Blood Institute / Columbia University / University of California at Davis / University of Kentucky / Wake Forest University / University of Florida / Beth Israel Deaconess Hospital / American College of Cardiology / University of Miami / Medical College of Virginia / Brown University / /
IndustryTerm
media ad / detailed demonstration and repeated device / nonprescription medical device / wrist device / equipment manufacturer / prescription devices / diagnostic device / overthecounter device / final product / telephone interaction / larger / benign device / computer software / direct subscriber communications / personal heart device / harmless device / nonprescription device / predicate device / telephone conversation / telephone lines / insurance plans / electrode technology / followup protocol / chest using metal electrodes / /
cardiac surgery / catheterizations / cardiovascular surgery / /
Organization
Brown University Medical School / North American Society of Pacing and Electrophysiology / Columbia University / University of California / General Hospital Advisory Panel / National Heart / Lung / and Blood Institute / Circulatory System Devices Panel / North American Society for Pacing and Electrophysiology / Center for Devices and Radiological Health / Beth Israel Deaconess Hospital in Boston / the American College / NASPE Executive Committee / Wake Forest University / FOOD AND DRUG ADMINISTRATION / Brown University / Virginia Commonwealth University / Professional Society of Electrophysiologists and Scientists / University of Miami / Cardiology and American Heart Association / Medical Devices Advisory Committee / Medical College of Virginia / University of Kentucky / NASPE Health Policy Committee / University of Florida / Bowman Gray School of Medicine / /
Person
David Brill / Julie A. Swain / Rosie Gilliam / Elizabeth E. Jacobson / Alan Morgan / Ronald Weintraub / D. Bruce Burlington / Sethi / Jeff Brinker / David A. Gooray / Lowell Harmison / Ron Weintraub / T. SIMMONS / Medox Medicals / Tony Simmons / Wayne Moseley / Jeffery A. Brinker / Catherine Faust / Dan Spyker / Joe Smith / Jean A. Goggins / D. Ronald M. Weintraub / Cynthia Tracy / Ronald M. Weintraub / D. Tony W. Simmons / John E. Stuhlmuller / Thomas J. Callahan / John Hoggle / Anne B. Curtis / Paul Costello / Reggie Lewis / M.D. Gabriel Gregoratos / Daniel A. Spyker / Gabe Gregoratos / Gabriel Gregoratos / George W. Vetrovec / J. SIMMONS / D. Francis B. Gilliam / Jacqueline Simmons / Carole Carey / / /
Position
designated physician / President / Chairman and Chief Executive Officer / physician / the monitoring service / physician / consulting physician / one of the panel members / advocate / supervisor / Executive Secretary / Vice President of Operations / individual physician / Chairperson / REPRESENTATIVE / clinical cardiologist / cardiac surgeon / speaker / Medical Director / adjunct assistant professor / technician / subscriber representative / consumer representative / cardiologist / physician for whatever reason / Chairman / science adviser / Director / health policy analyst / the Deputy Director for DCRND / Executive Vice President / practicing cardiologist / industry representative / company representative / assistant clinical professor / /
Product
K944362 / K963904 / /
ProgrammingLanguage
R / C / /
ProvinceOrState
Virginia / Rhode Island / California / Georgia / Kentucky / Florida / /
PublishedMedium
the Ladies Home Journal / the Washington Post / /
Technology
medical protocols / followup protocol / electrode technology / the Personal Heart Device / AV / /
ajh MILLER REPORTING COMPANY, INC. 507 C Street, N.E. Washington, D.C[removed][removed]ATDEPARTMENT OF HEALTH AND HUMAN SERVICES