FDA PMA database search for device approvals and supplements

The FDA PMA database lets you look up premarket approval decisions and supplements for devices that require PMA. Start with the FDA PMA search. The openFDA API also supports searches by device, applicant, product code or PMA number.

PMA is FDA's scientific and regulatory review of Class III devices for safety and effectiveness. Approval requires sufficient valid scientific evidence for the intended uses. But some preamendment Class III devices can require a Class III 510(k) instead. Don't assume every Class III device has a PMA. FDA's PMA guidance draws that line.

How to search the FDA PMA database

If you know the three-letter product code, FDA's instruction is for a classification check: enter only that code in the product-code box when you search the PMA and 510(k) databases. FDA's PMA guidance states that step.

For searches by other identifiers, openFDA documents searchable PMA fields separately from the website. Its PMA field explorer lists:

• applicant for the applicant name.
• trade_name and generic_name for device names.
• product_code for the device's product code.
• pma_number for the assigned application number.
• supplement_number for the supplement identifier.

These are API field names, not labels on the AccessData form. Keep the two routes separate when you write down how you searched.

For a worked PMA-number search, open this official API query for P210001:

https://api.fda.gov/device/pma.json?search=pma_number:P210001&limit=100

The expression pma_number:P210001 requests records sharing that PMA number. The API response includes the original approval and supplement S012. Both identify the VENTANA MMR RxDx Panel and Ventana Medical Systems, Inc. (Roche Tissue Diagnostics). The original record also lists product code QNH and docket 21M-0915. This example uses JSON records rather than a website click path.

Read the PMA number and supplement separately

FDA defines pma_number as its assigned application number, including leading letters, and the prefix P means Premarket Approval. The supplement has a separate field, so retain both identifiers when citing a particular change. openFDA's field definitions are the source for that split. The P210001 records show it.

Both entries come from the same FDA API query. The original indication summary is not complete current labeling, and this result does not establish current commercial status.

S012's supplement type is "Normal 180 Day Track" (the label is not a timer). Its receipt and decision dates are the ones in the table. And the track name does not promise that the elapsed review will take 180 days. Those dates and that type are in the S012 record.

What a PMA record tells you

Read the applicant and device names alongside the identifiers. FDA's documented output includes classification name, generic name, trade name, applicant, product code and advisory committee, plus receipt and decision dates, supplement type and reason, expedited-review status and the approval-order statement. FDA's PMA approvals page lists those output fields. The list is not a map of website search boxes.

Use the approval-order statement to identify the scope of the decision. Keep receipt and decision dates distinct: they describe different events. For a supplement, read its type and reason alongside that statement rather than treating it as another original approval.

The applicant name also needs care. FDA says the PMA reference number stays unchanged after an ownership transfer, so a current applicant name does not establish who owned the original application. The PMA FAQ states that rule.

Find the supporting approval documents

Look for the approval order, summary of safety and effectiveness, and product labeling. FDA says these documents are available through links from the searchable PMA database. Check the documents attached to the record you need rather than assuming every entry has the same files. The PMA FAQ is the source for those links.

A public record does not give you the entire submission. FDA protects trade secrets, confidential commercial and financial information, and personal information. Manufacturing information also has disclosure limits. The same FAQ sets those limits.

Some review material is public. FDA describes a transparency pilot that releases summary review memos for some 180-day PMA design-change supplements. Don't expect a memo for every supplement. FDA's medical-device databases page describes the pilot.

If your FDA PMA search finds nothing

An FDA device database search is broader than PMA. The PMA database is not a complete list of all FDA-authorized medical devices. If you need an FDA clearance database, check the 510(k) route instead. Keep PMA approval, 510(k) clearance and De Novo grants distinct. Check which pathway applies before drawing a conclusion:

• A 510(k) demonstrates substantial equivalence to a legally marketed predicate. FDA clears the device rather than granting PMA approval.
• De Novo covers novel devices without a legally marketed predicate, where general controls, or general and special controls, are sufficient. A granted device is classified into Class I or II.
• Establishment registration and device listing do not denote approval, clearance or authorization.

An unsuccessful search also cannot rule out a pending application. FDA generally does not disclose a PMA's existence before approval or disapproval unless it has already been publicly disclosed or acknowledged. Even then, public acknowledgment does not make the whole file available. The PMA FAQ states that limit.

Updates and bulk downloads

FDA lists the searchable PMA database's update schedule as once a week. For bulk work, its PMA approvals page describes a downloadable pma.zip containing releasable information. FDA replaces that file monthly, usually on the fifth. These are different schedules for different resources.

RegAffairs AI has a worked answer on searching PMA records and reading supplements.

For the API example above, the response metadata reports a last-updated date of 2026-10-19. That timestamp does not establish that every FDA website record is synchronized. The date is in the FDA API response.