Pure Global AI
Free FDA PMA search · No signup

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.

Original PMAs and supplementsDecision historyDirect source verificationopenFDA Premarket Approval API

Search FDA PMA approvals

Try an example

Find PMA applications and supplements by device or trade name, applicant, PMA number, or FDA product code.

Search by
About the data

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.

Read the official FDA dataset documentation

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.
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.

Continue your research

FDA Predicate & Pathway Agent
Research across all FDA datasets from one device description.
FDA TPLC Intelligence Report
Connect classification, approvals, listings, recalls, MAUDE, and GUDID by product code.
FDA 510(k) Database
Find clearances, applicants, and predicates.
FDA Product Code Lookup
Find product codes, device classes, and regulatory pathways.
FDA Medical Device Recalls
Search recall events, firms, reasons, and affected products.
FDA GUDID / UDI Lookup
Identify exact device models and labeler records.
FDA De Novo Database
Find novel device classification decisions.
FDA Registration & Listing
Search establishments and listed devices.
FDA MAUDE Safety Reports
Search post-market medical device reports.
FDA Recognized Standards
Find current recognition records, versions, and recognition extent.
Keep researching this market

More United States medical device resources

View the United States resource hub →
Continue with this market