Premarket Approval

A Premarket Approval (PMA) application is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of medical devices.  This is the most stringent type of device marketing application required by FDA. To gain approval, the manufacturer must present adequate scientific evidence to assure that the device is safe and effective for its intended use.  

Medicare Fiscal Intermediary approval is only required for Post-Market Approval (PMA) Carotid Stent studies.

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