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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Premarket Approvals and Humanitarian Device Exemptions with Supporting Documents

This list includes applications for which we have approval documents available, and reflects the information as of the approval date. It is not updated with regard to applicant or application status changes. Information is arranged in alphabetical order by the name of the applicant. 

Complete List of Currently Approved Premarket Approvals (PMAs) (PDF - 28 KB)




Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002