What is an FDA PMA?
Premarket Approval is FDA’s scientific and regulatory review pathway for many Class III devices. An approved application permits marketing for the approved device and indications.
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FDA PMA Database Search
Search original Premarket Approval applications and supplements for high-risk medical devices, including applicants, decision dates, approval statements, and product codes.
Direct FDA source dataFree, no account requiredOfficial record links
Original PMAs and supplements
Review both original applications and later changes to approved Class III devices.
Decision history
See FDA receipt dates, decision dates, supplement types, and approval statements.
Direct source verification
Open the related FDA PMA record for documents and the complete administrative history.
Search FDA PMA approvals
Find PMA applications and supplements by device or trade name, applicant, PMA number, or FDA product code.
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Important interpretation note
PMA records describe FDA decisions for specific applications and supplements. Confirm the exact device version, indication, applicant, and approval documents before drawing a regulatory conclusion.
How to read PMA search results
The base PMA number identifies the original application. A supplement number identifies a later change such as new labeling, manufacturing, design, or indications.
Review the decision code and approval-order statement together. A supplement approval applies to the change described in that record, not a new blanket approval of the device.
Use the official FDA PMA page to inspect approval orders, Summary of Safety and Effectiveness Data, labeling, and supplement history before relying on a result.
Frequently asked questions
Why are there multiple records for one PMA number?
The PMA dataset includes supplements submitted after the original approval. Each supplement can cover a different design, labeling, manufacturing, or indication change.
Does “approved” apply to every version of a product?
No. Approval is tied to the application, device configuration, labeling, and indications described in the FDA record and supporting documents.
How often is the PMA data updated?
FDA states that the openFDA PMA endpoint is updated monthly. The search result shows the source update date when available.