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In this section: Approved Blood Products

Premarket Approvals (PMAs) and Humanitarian Device Exemptions (HDEs)

The following products are regulated as Premarket Approvals (PMAs): Devices associated with blood donor testing.

List of Premarket Approvals

Information is arranged in alphabetical order by the name of the applicant.

Related Information

Premarket Approval (PMA) for CBER-Regulated Products
Development & Approval Process information

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List of Premarket Approvals

Related Information

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