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What is the Format & Content for a Premarket Approval (PMA) Submission?

What is the Format & Content for a Premarket Approval (PMA) Submission?. Carole C. Carey BSEE, MEng carole.carey@fda.hhs.gov Director, International Staff US Food and Drug Administration (USFDA) Center for Devices and Radiological Health (CDRH). Learning Objectives.

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1.06k views • 43 slides

Translational Pathway For Left Ventricular Assist Devices:

Francis D. Pagani , MD PhD Otto Gago MD Endowed Professor of Cardiac Surgery Department of Cardiac Surgery University of Michigan. The Methods For LVAD Development. Translational Pathway For Left Ventricular Assist Devices:. Disclosure Statement of Financial Interest.

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229 views • 22 slides

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Pma approval - PowerPoint PPT Presentation

What is the Format &amp; Content for a Premarket Approval (PMA) Submission?

Translational Pathway For Left Ventricular Assist Devices:

What is the Format & Content for a Premarket Approval (PMA) Submission?