Searching the FDA PMA Database
How do I search the FDA PMA database?
You can search PMA records in two ways. One is FDA's own Premarket Approval (PMA) database form on accessdata.fda.gov. The other is to ask here, because the FDA CDRH PMA decisions are in the datasets I search. Each record covers one original PMA or one supplement decision, identified by PMA number plus supplement number.
On FDA's site (PMA database search), you can fill in any combination of these fields:
- Applicant name, device name, product code, PMA number, docket number
- Decision date, with a date range
- Advisory committee (for example Cardiology, Orthopedics, Anesthesiology)
- Supplement type (Original, Normal 180-Day Track, Special Supplement and others)
- Expedited review (Yes/No), cleared/approved IVD products, combination products
- Center (Biologics, or Devices/Radiological Health)
- Whether a Predetermined Change Control Plan was authorized
You can sort results by decision date, trade name, applicant or PMA number. The page also offers a simpler Quick Search, a Help/FAQ link, and a Download Files option if you want the PMA approval data in bulk.
Here, ask in plain language. I can look up records by:
- Exact match: PMA number, supplement number, product code, advisory committee code, supplement type, decision code, decision date or date received (MM/DD/YYYY), docket number
- Name search: applicant, generic name, trade name, supplement reason, or any text on the PMA detail page
For example, looking up P850006 returns the original approval record:
- Applicant: Edwards Lifesciences, LLC
- Trade name: Duromedics Bileaflet Heart Valve (generic name "Heart-Valve, Mechanical")
- Product code LWQ, advisory committee CV
- Decision date 08/29/1986, decision code APWD
These kinds of questions work well:
- "List all PMA supplements for product code LWQ approved since 2020"
- "Which PMAs does [applicant] hold for [device type]?"
- "Show the supplement history and reasons for P______"
I can also pull related CDRH guidance and Medical Devices Advisory Committee meeting records.
Approach: I opened FDA's official PMA database search page and ran a sample lookup in the FDA CDRH PMA decisions dataset.
What do PMA records and supplements show?
A PMA record is FDA's summary of one decision. The original record covers the first approval of the device. Each supplement record (S001, S002 and so on) covers one later change to that approved device: what changed, which review track it went through, when FDA received it and how FDA decided. The supplement records also carry a short Approval Order Statement saying what was approved.
What an original PMA record shows (example: P850006, Edwards Lifesciences' Duromedics Bileaflet Heart Valve) [1]:
- The device: trade name, generic name ("Heart-Valve, Mechanical") and product code (LWQ).
- The applicant: name and address.
- The review: advisory committee (Cardiovascular), date received (02/04/1985), decision date (08/29/1986) and decision code (APWD).
- Status: a withdrawal date where there is one; this record shows 01/28/2022.
- Publication: docket number (86M-0377) and Federal Register notice date (09/26/1986).
- Flags: expedited review granted, combination product, and Predetermined Change Control Plan authorized. All three are "No" here.
- This record has no supplements on file.
What a supplement record adds
- Supplement number: tied to the parent PMA number.
- Supplement type: the review track.
- Supplement reason: a standard category of change.
- Approval Order Statement: free text describing exactly what FDA approved.
- Decision code: varies by track. For example, OK30 on 30-day notices and APPR on approvals.
| PMA / supplement | Type | Reason | Received → decided | Code | What changed (Approval Order Statement) |
|---|---|---|---|---|---|
| P990055/S001, Siemens ADVIA Centaur cPSA [2] | Normal 180 Day Track | Change Design/Components/Specifications/Material | 03/27/2001 → 12/07/2001 | APPR | Added the assay to the ACS:180 and ADVIA Centaur analyzers, and restated the indications |
| P210001/S012, Ventana MMR RxDx Panel [3] | Normal 180 Day Track | Change Design/Components/Specifications/Material | 12/11/2023 → 12/20/2024 | APPR | Moved the assay from the BenchMark ULTRA platform to BenchMark ULTRA PLUS |
| P930027/S019, Siemens Immulite PSA [4] | Special (Immediate Track) | Labeling Change - Indications/instructions/shelf life/tradename | 03/19/2018 → 04/16/2018 | APPR | Updated the high-dose hook effect claim in the Instructions for Use |
| P930039/S007, Medtronic SureFix pacing lead [5] | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 01/05/2000 → 01/28/2000 | OK30 | Changed the connector ring backfilling process |
| P960042/S005, Spectranetics Laser Sheaths [6] | 135 Review Track For 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 09/28/1999 → 03/17/2000 | APPR | Added ethylene oxide sterilization equipment |
| P980022/S184, Medtronic MiniMed Paradigm pumps [7] | 30-Day Notice | Process Change - Manufacturer/Sterilizer/Packager/Supplier | 11/04/2015 → 12/04/2015 | OK30 | Moved assembly of the motor gearbox from manual to automated |
Practical use
- The full history of a device: pull every supplement under one PMA number to see its design, labeling, manufacturing and sterilization changes over time. The P980022 example above is already at supplement S184.
- Change pathways for a device type: filter by product code and supplement reason to see which review track FDA has used for comparable changes, such as a supplier or process change going through a 30-Day Notice versus a 135-day track.
The records don't contain the underlying submission, review memos or test data. They only hold FDA's summary of each decision.
Approach: I read the original approval for P850006 and supplement records from several other PMAs in the FDA CDRH PMA decisions dataset.