FDA PMA device approvals
Premarket approvals (PMA) of high-risk medical devices and their supplements: PMA and supplement number, trade and generic name, applicant with address, decision code and date, date received, supplement type and reason, product code, advisory committee, expedited review, docket number and approval order statement. Newest decisions first by default. Filters accept a comma list (any of the values). Pass next_page back as page; null on the last page.
With count_by=<field> the response gives facet counts of the matching records by that field instead of the records: items of {term, count} (top count_limit). Text fields count whole values on their .exact index (e.g. count_by=openfda.manufacturer_name.exact); date fields give a time series grouped by count_interval (items of {period, count}). The other filters narrow what is counted.
Every response includes credits_used: the credits this call cost.
Parameters
| name | type | description |
|---|---|---|
pma_number | string | PMA number (e.g. P970004). Example: P970004 |
applicant | string | Applicant name. |
trade_name | string | Trade name. |
generic_name | string | Generic name. |
product_code | string | Three-letter product code. |
committee | string | Two-letter advisory committee code. |
supplement_type | string | Supplement type (e.g. 30-Day Notice). |
decision_code | string | Decision code (e.g. APPR). |
q | string | Free-text words; every word must appear somewhere in the record. |
from | string | Earliest date (YYYY-MM-DD) of the route's main date field. |
to | string | Latest date (YYYY-MM-DD). |
search | string | An openFDA query expression added to the filters with AND, for fields the named filters do not cover (e.g. openfda.route:"TOPICAL"). |
sort | decision_date | date_received | Sort field (default: relevance, or the newest first where noted). |
order | desc | asc | Sort order (default desc). |
limit | integer | Results per page. |
page | integer | Page number (1-based). Pass next_page back as page; null on the last page. |
count_by | string | Count the matching records by this field (an openFDA field name, e.g. classification.exact, openfda.brand_name.exact, or a date field). |
count_limit | integer | Number of top terms for count_by (1-1000; default 100). |
count_interval | year | month | day | Grouping of a date count_by: year (default), month or day. |
Every endpoint also takes fresh, raw, fields (see lean responses and caching).
Example
curl "https://api.api.sh/openfda/v1/devices/pma?pma_number=P970004" \
-H "x-api-key: $APISH_KEY" import os, requests
res = requests.get(
"https://api.api.sh/openfda/v1/devices/pma",
params={"pma_number": "P970004"},
headers={"x-api-key": os.environ["APISH_KEY"]},
timeout=120,
)
res.raise_for_status()
data = res.json() const url = new URL("https://api.api.sh/openfda/v1/devices/pma");
url.searchParams.set("pma_number", "P970004");
const res = await fetch(url, { headers: { "x-api-key": process.env.APISH_KEY } });
if (!res.ok) throw new Error(`${res.status} ${await res.text()}`);
const data = await res.json(); Response
A JSON object with the fields described above, plus raw (the source's own data), cached, fetched_at and credits_used. Errors return {"success": false, "error": "…"} with the HTTP status (see errors). A lookup that ran but found nothing (404) costs the price above; refused calls and errors on our side are free (what's charged).