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Company Medtronic / Cummins / / Country United States / / Event FDA Phase / / IndustryTerm off-label bare metal stents / / MedicalCondition pulmonary artery conduits / disease / / MedicalTreatment balloon catheter / open heart surgery / open-heart surgeries / surgery / surgeries / / Organization Device Evaluation Center for Devices / Food and Drug Administration / Pediatric Advisory Committee / Mechanical Engineer Lead Reviewer Office / / Person John Sapirstein / Carolyn D. Vaughan / Jenny Chih-Hsin Liu / John S. Sapirstein / Lead Reviewer / Philipp Bonhoeffer / Dale Tavris / / Position representative / Professor / Cardiothoracic Surgeon Office / / Product ADN / /
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