PMA Database: How to Search FDA Premarket Approvals and Read a Record

Short answer: the PMA database is the FDA’s public search page for premarket approval (PMA) applications and supplements. Each record shows who applied, the device and product code, the received and decision dates, the approval order statement, and links to the approval order, the summary of safety and effectiveness, and labeling. It covers Class III devices, which FDA approves rather than clears. This is general regulatory information, not medical advice.

Definition and scope

FDA describes premarket approval as its process of scientific and regulatory review to evaluate the safety and effectiveness of Class III devices. FDA describes Class III devices as those that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury. For these devices the applicant must receive FDA approval of its PMA application before marketing the device.

The PMA database is where those approvals are listed. openFDA publishes a related PMA dataset that contains details about specific products and the sponsors of premarket approval applications and supplements, including administrative and tracking information and receipt and decision dates. For the clearance side, see our guide to the FDA 510(k) database.

How to search the PMA database

The FDA search page offers these search fields:

• Applicant, Device, and Product Code
• PMA Number and Docket Number
• Decision Date (from and to)
• Advisory Committee
• Expedited Review (yes or no)
• Supplement Type, with options such as Originals Only, Normal 180 Day Track, Panel Track, Real Time Process and 30 Day Notice
• Combination Products, Center, and Predetermined Change Control Plan Authorized
• Cleared/Approved IVD Products

Results can be sorted by decision date, trade name, applicant or PMA number, and the page offers a download option for PMA approvals. FDA’s PMA overview suggests searching by the three-letter product code when you know it.

How to read a PMA record

The record below is an illustration of layout only, using PMA P160013 (the TransMedics OCS Lung). Not every record carries every field or link.

Label on the record	What it tells you
PMA Number (P160013)	Identifies the original application. Supplements to it are listed separately as S001, S002 and so on; this record lists S001 to S021.
Date Received / Decision Date	When FDA received the application (04/28/2016) and when it decided (03/22/2018).
Applicant, Device, Generic Name	The company that holds the application, the trade name, and the generic device name.
Product Codes	The three-letter code you can reuse to search for related devices.
Docket Number, Notice Date	FDA docket reference (18M-1237 in this example) and the notice date for the decision.
Advisory Committee	The FDA advisory committee listed for the record.
Clinical Trials	An NCT number linking the record to the registered study.
Expedited Review Granted? / Combination Product / Predetermined Change Control Plan Authorized	Yes or no flags about how the application was handled and whether a change control plan was authorized.
Approval Order Statement	FDA’s own wording of what was approved. Read this, not marketing copy, to see the approved use.

The record also links to the Approval Order (P160013A.pdf), the Summary of Safety and Effectiveness Data, or SSED (P160013B.pdf), and the labeling files (P160013C.pdf and P160013D.pdf), and it lists a post-approval study schedule. FDA notes that the labeling shown is from the original approval and may not reflect the most recent labeling.

PMA record versus 510(k) record

FDA’s PMA overview uses the word “approval” for PMA devices and reserves “cleared” for 510(k)s. A PMA number starts with P; the 510(k) database uses its own K numbers. The two databases answer different questions, and the comparison pages explain the pathways in depth: 510(k) vs PMA and FDA clearance vs approval. For the wider regulatory picture, see FDA medical device classification, 510(k) and PMA.

Where it matters for labs, clinics and supply decisions

A checklist built from the fields above, for staff who need to confirm that a Class III device has an FDA approval on record:

1. Find the record by PMA number, applicant, or product code.
2. Confirm the applicant and device name match the product you are looking at.
3. Read the Approval Order Statement and compare it with the intended use you have in mind.
4. Check the supplements list, since changes after the original approval are filed as supplements.
5. Remember that the labeling on the record is from the original approval; use the manufacturer’s current labeling for use instructions.

A record shows a regulatory decision about one device. It does not show price, stock or availability, and it is not an endorsement. For background on what counts as a device, see what is a medical device.

Common misunderstandings

• “Cleared” and “approved” are interchangeable. FDA’s PMA page uses approval for PMA devices; clearance belongs to 510(k).
• Every device is in this database. It lists PMA applications and supplements for Class III devices, not 510(k) clearances.
• An approval covers any similar product. The record is specific to the device and the approval order statement.
• The labeling on the record is current. FDA notes it reflects the original approval.

FAQ

What is the PMA database?

It is FDA’s searchable listing of premarket approval applications and supplements for Class III devices, with decision dates, applicants, product codes and links to approval documents.

How does PMA differ from clearance?

PMA is FDA approval after review of safety and effectiveness for Class III devices. Clearance is the 510(k) outcome. See 510(k) vs PMA.

Can I download PMA data?

The FDA search page has a download option for PMA approvals, and openFDA publishes a PMA dataset that it describes as updated monthly.

Sources

• FDA, Premarket Approval (PMA) database, checked 2026-10-30.
• FDA, PMA record P160013, checked 2026-10-30.
• FDA, Premarket Approval (PMA), checked 2026-10-30.
• openFDA, Device PMA, checked 2026-10-30.