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Pharmacology / Health / Cardiology / Clinical research / Pharmaceutical industry / Humanitarian Device Exemption / Ventricular outflow tract / Clinical trial / Medicine / Pharmaceutical sciences / Food and Drug Administration


Medical Device Trial Design for the Business Professional: Lessons Learned
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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 / /

SocialTag