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How can I find more information about a Premarket Approval (PMA) for a medical device under review?
Before FDA approves or disapproves a PMA, FDA will not disclose the existence of the PMA unless it previously has been publicly disclosed or acknowledged. Even if the existence of the PMA has been publicly disclosed or acknowledged, data or information contained in the file are not available for public disclosure. However, FDA may disclose a summary of portions of the safety and effectiveness data, if disclosure is relevant to public consideration of a specific pending issue. [21 CFR 814, 21 CFR 20]
U.S. Food and Drug Administration (FDA)
http://www.fda.gov
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