Premarket Approval

A PMA is an application submitted to FDA to request approval to market a medical device.

About PMA

Premarket Approval (PMA) is the most stringent type of device marketing application required by FDA. A PMA is an application submitted to FDA to request approval to market. Unlike premarket notification, PMA approval is to be based on a determination by FDA that the PMA contains sufficient valid scientific evidence that provides reasonable assurance that the device is safe and effective for its intended use or uses.

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General information
Learn more about Premarket Approval

Original dataset downloads
PMA download information

Provider

FDA

Updates

Frequency Monthly

Time period

Earliest data 1976

Current through Current