FDA PMA Medical Device Approvals Scraper (openFDA)

Here is one real result, with every field the actor returns:

{
  "pmaNumber": "P170030",
  "supplementNumber": "S065",
  "isOriginal": false,
  "applicant": "Biotronik AG",
  "tradeName": "ORSIRO Sirolimus Eluting Coronary Stent System",
  "genericName": "Coronary drug-eluting stent",
  "productCode": "NIQ",
  "advisoryCommittee": "CV",
  "specialty": "Cardiovascular",
  "supplementType": "Normal 180 Day Track No User Fee",
  "supplementReason": "Postapproval Study Protocol",
  "expeditedReview": false,
  "dateReceived": "2026-07-10",
  "decisionDate": "2026-08-07",
  "decision": "Approved",
  "decisionCode": "APPR",
  "daysToDecision": 28,
  "docketNumber": null,
  "statement": "Post Approval Study Protocol for the EVO Extended Diameter PAS",
  "applicant_street1": "Ackerstrasse 6",
  "applicant_street2": null,
  "city": "Bülach",
  "state": null,
  "zip": "8180",
  "applicantAddress": "Ackerstrasse 6, Bülach, 8180",
  "pmaUrl": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P170030S065",
  "openfda": {
    "device_name": "Coronary Drug-Eluting Stent",
    "device_class": "3",
    "registration_number": ["3008132398", "1000121056"],
    "fei_number": ["1000121056", "3002806434"]
  },
  "aiSummary": null,
  "aiDeviceCategory": null,
  "aiBodySystem": null,
  "aiRiskLevel": null,
  "aiTags": null,
  "observedAt": "2026-08-20T00:36:17.734Z",
  "error": null
}

The most complete FDA Premarket Approval (PMA) scraper available. It returns every field the openFDA device PMA database exposes for each approval and supplement, plus derived fields (decision in plain English, daysToDecision, isOriginal, applicantAddress, pmaUrl), optional AI enrichment, and fourteen filters to target exactly the device approvals you need.

📥 Input · 📤 Output · 💰 Pricing · ▶️ Examples

Table of contents

• What it does
• Use cases
• Quickstart
• Input reference
• Output reference
• Example output record
• Run via API and CLI
• Fetch results
• Billing
• FAQ and troubleshooting

What it does

The actor queries the openFDA device PMA dataset, applies the filters you pass as input, paginates through the matching approvals, and writes one normalized record per PMA record (original approval or supplement) to the run's dataset. PMA is the FDA's most stringent device review pathway, used for Class III high-risk devices such as coronary stents, heart valves, pacemakers, implantable defibrillators, spinal implants, and intraocular lenses.

Dates are normalized to YYYY-MM-DD, missing source values are returned as null, and derived fields are computed on top of the raw FDA fields: a plain-English decision, daysToDecision (received to decision), isOriginal (original approval versus supplement), a single-line applicantAddress for CRM or mapping, and a direct pmaUrl into the FDA database.

Two optional AI add-ons (opt-in, off by default) enrich each record: a plain-English summary of what the device is and what the approval covers, and a structured classification (device category, body system, risk level, keyword tags).

This actor covers PMA decisions only. For 510(k) clearances of moderate-risk devices, see the FDA 510(k) Clearances Scraper. For device recalls, see the FDA Drug & Device Recalls Scraper.

Use cases

• Medtech competitive intelligence. Track every PMA approval and supplement for a competitor by applicant and watch new device launches, label expansions, and manufacturing changes.
• Regulatory affairs monitoring. Follow approvals in your specialty (Cardiovascular, Orthopedic, Ophthalmic, Neurology) and benchmark FDA review timelines with daysToDecision.
• Investment and market research. Surface newly approved high-risk devices, expedited-review approvals, and Panel Track supplements to spot commercial and clinical inflection points.
• Supply chain and sourcing. Map applicant companies, addresses, and the registration and FEI numbers of manufacturing establishments in the openfda block.
• Clinical and academic research. Build a dataset of approved Class III devices by product code, generic name, and approval date.
• Sales lead generation. Export applicant companies and single-line addresses to target medtech manufacturers and their suppliers.

Quickstart

Open the actor, paste this into the input, and press Run. It returns the 10 most recent approved cardiovascular device PMAs, newest first.

{
  "specialty": "Cardiovascular",
  "decisionCode": "APPR",
  "sortOrder": "Newest first",
  "maxResults": 10
}

Leave every filter empty to pull the most recent PMA records with no filter. All input fields are optional. Free Apify accounts return up to 10 records per run.

Input reference

Field	Type	Required	Default	Description
searchQuery	string	no	(empty)	Free-text search against the device trade name (for example stent), OR a raw openFDA field expression such as generic_name:pacemaker. A value containing field: is treated as a raw expression.
applicant	string	no	(empty)	Applicant company that holds the PMA, exact phrase, for example Medtronic, Abbott, Boston Scientific.
tradeName	string	no	(empty)	Device trade (brand) name phrase.
genericName	string	no	(empty)	Device generic name or type, for example Coronary drug-eluting stent.
productCode	string	no	(empty)	Three-letter FDA product code, for example NIQ, ONU, LPL.
specialty	enum	no	(any)	FDA advisory committee (medical specialty) that reviewed the device, for example Cardiovascular, Orthopedic, Ophthalmic.
decisionCode	enum	no	(any)	FDA decision code. APPR approved, OK30 30-day notice acknowledged, APWD approved then withdrawn, APRL approvable, DENY denied.
supplementType	enum	no	(any)	PMA supplement track, for example Normal 180 Day Track, Panel Track, Real-Time Process, 30-Day Notice.
state	string	no	(empty)	Applicant two-letter US state code, for example CA, MN, MA.
pmaNumber	string	no	(empty)	Look up a specific PMA number, for example P160049.
expeditedOnly	boolean	no	false	Only return devices that received expedited (priority) FDA review.
originalOnly	boolean	no	false	Only return original PMA approvals (exclude supplements and notices).
dateFrom	string	no	(empty)	Include records on or after this date (YYYY-MM-DD). Applies to dateField.
dateTo	string	no	(empty)	Include records on or before this date (YYYY-MM-DD). Applies to dateField.
dateField	enum	no	decision_date	Which date the range applies to: decision_date or date_received.
sortOrder	enum	no	(relevance)	Newest first or Oldest first, ordered on dateField. Empty keeps openFDA relevance order.
withSummary	boolean	no	false	Opt-in AI add-on. Add a plain-English summary per record. Billed only when a summary is produced. Disabled for free accounts.
withClassify	boolean	no	false	Opt-in AI add-on. Add device category, body system, risk level, and tags per record. Billed only when a classification is produced. Disabled for free accounts.
maxResults	integer	no	50 (prefill 10)	Maximum records to collect. Free accounts are capped at 10 per run.
proxyConfiguration	object	no	(none)	Standard Apify proxy configuration. Not required; the source is a public no-key API.

Filters combine with logical AND. If you pass no filters, the actor returns PMA records ordered by openFDA relevance.

Output reference

One dataset item per PMA record. Types: string, integer, boolean, string[], object, or null when the source value is absent.

Field	Type	Description
pmaNumber	string	FDA PMA number, for example P160049.
supplementNumber	string	Supplement number, for example S008. Empty or zero for original approvals.
isOriginal	boolean	true for the original PMA approval, false for a supplement or notice.
applicant	string	Applicant company that holds the PMA.
tradeName	string	Device trade (brand) name.
genericName	string	Device generic name or type.
productCode	string	Three-letter FDA product code.
advisoryCommittee	string	Advisory committee code, for example CV.
specialty	string	Advisory committee (medical specialty) description.
supplementType	string	PMA supplement track.
supplementReason	string	Reason for the supplement, for example Process Change, Labeling.
expeditedReview	boolean	true when the device received expedited (priority) review.
dateReceived	string	Date the FDA received the submission (YYYY-MM-DD).
decisionDate	string	Date of the FDA decision (YYYY-MM-DD).
decision	string	Plain-English decision derived from decisionCode.
decisionCode	string	Raw FDA decision code, for example APPR, OK30.
daysToDecision	integer	Whole days between dateReceived and decisionDate, or null.
docketNumber	string	Federal docket number when present, else null.
statement	string	FDA action or order statement describing the decision.
applicant_street1	string	Applicant street address line 1.
applicant_street2	string	Applicant street address line 2, or null.
city	string	Applicant city.
state	string	Applicant state code.
zip	string	Applicant ZIP code (with extension when present).
applicantAddress	string	Single-line applicant address, ready for CRM or mapping.
pmaUrl	string	Direct link to the record in the FDA PMA database.
openfda	object	The openFDA harmonization block (device name, class, registration and FEI numbers), or null.
aiSummary	string	AI plain-English summary of the device and approval, or null when the add-on is off.
aiDeviceCategory	string	AI device category, or null when the add-on is off.
aiBodySystem	string	AI affected body system, or null when the add-on is off.
aiRiskLevel	string	AI risk level (high, medium, low), or null when the add-on is off.
aiTags	string[]	AI keyword tags, or null when the add-on is off.
observedAt	string	ISO 8601 timestamp of when the record was collected.
error	string	null on success. On a failed run, a single item with a populated error field is written instead.

Example output record

Real record from a live run (input {"applicant": "Medtronic", "decisionCode": "APPR", "maxResults": 5}):

{
  "pmaNumber": "P130021",
  "supplementNumber": "S016",
  "isOriginal": false,
  "applicant": "Medtronic, Inc.",
  "tradeName": "MEDTRONIC COREVALVE AND COREVALVE EVOLUT R SYSTEMS",
  "genericName": "Aortic valve, prosthesis, percutaneously delivered",
  "productCode": "NPT",
  "advisoryCommittee": "CV",
  "specialty": "Cardiovascular",
  "supplementType": "Normal 180 Day Track",
  "supplementReason": "Labeling Change - Indications/instructions/shelf life/tradename",
  "expeditedReview": false,
  "dateReceived": "2015-07-08",
  "decisionDate": "2015-11-10",
  "decision": "Approved",
  "decisionCode": "APPR",
  "daysToDecision": 125,
  "docketNumber": null,
  "statement": "APPROVAL FOR MODIFYING THE LABELING TO REMOVE THE PRECAUTIONS REGARDING PATIENTS WITH LOW FLOW/LOW GRADIENT AND END-STAGE RENAL DISEASE.",
  "applicant_street1": "710 Medtronic Pkwy.",
  "applicant_street2": null,
  "city": "Miinneapolis",
  "state": "MN",
  "zip": "55432",
  "applicantAddress": "710 Medtronic Pkwy., Miinneapolis, MN 55432",
  "pmaUrl": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P130021S016",
  "openfda": null,
  "aiSummary": null,
  "aiDeviceCategory": null,
  "aiBodySystem": null,
  "aiRiskLevel": null,
  "aiTags": null,
  "observedAt": "2026-08-20T00:36:17.000Z",
  "error": null
}

Run via API and CLI

Start a run and wait for it to finish, then read the dataset. Replace <TOKEN> with your Apify API token.

Run synchronously and get dataset items in one call:

curl -X POST "https://api.apify.com/v2/acts/scrapers_lat~fda-pma-device-approvals-scraper/run-sync-get-dataset-items?token=<TOKEN>" \
  -H "Content-Type: application/json" \
  -d '{"specialty":"Cardiovascular","decisionCode":"APPR","maxResults":25,"sortOrder":"Newest first"}'

Start a run asynchronously:

curl -X POST "https://api.apify.com/v2/acts/scrapers_lat~fda-pma-device-approvals-scraper/runs?token=<TOKEN>" \
  -H "Content-Type: application/json" \
  -d '{"applicant":"Medtronic","maxResults":100}'

Apify CLI:

apify call scrapers_lat/fda-pma-device-approvals-scraper \
  --input '{"pmaNumber":"P160049"}'

Fetch results

Every run writes to a dataset. Fetch items as JSON, CSV, or Excel by changing format:

# JSON
curl "https://api.apify.com/v2/datasets/<DATASET_ID>/items?token=<TOKEN>&clean=true&format=json"

# CSV
curl "https://api.apify.com/v2/datasets/<DATASET_ID>/items?token=<TOKEN>&clean=true&format=csv"

# Paginate large datasets
curl "https://api.apify.com/v2/datasets/<DATASET_ID>/items?token=<TOKEN>&offset=1000&limit=1000"

<DATASET_ID> is returned as defaultDatasetId in the run object. Use offset and limit to page through large result sets. clean=true drops empty and internal fields.

Billing

This actor uses pay-per-event pricing. Prices follow a tiered discount ladder across Apify plan tiers (highest on the free tier, lowest on the Diamond tier).

Event	When it fires	Notes
apify-actor-start	Once per run at start	Covers run setup and query preparation.
result	Per PMA record returned	The primary event. One charge per normalized record written to the dataset.
ai_summary	Per record, only when withSummary is on and a summary is produced	Opt-in AI add-on. Off by default. Disabled for free accounts.
ai_classify	Per record, only when withClassify is on and a classification is produced	Opt-in AI add-on. Off by default. Disabled for free accounts.

• No charge on failure. If a run errors, the actor writes a single item with a populated error field and does not charge a result for it. Empty runs cost nothing.
• AI add-ons charge only on success. If the AI model returns nothing usable, no ai_summary or ai_classify charge is made and the fields stay null.
• Spend cap respected. Set maxTotalChargeUsd on the run; once reached, the actor stops emitting and charging further billable records.
• Free Apify plans are capped at 10 records per run, and paid AI add-ons are disabled for free accounts. Upgrade for higher maxResults and AI enrichment.
• Source pagination ceiling. openFDA allows a skip offset up to 25000 per query. For larger pulls, split the work with narrower filters or date ranges.

FAQ and troubleshooting

What is a PMA and how is it different from a 510(k)? Premarket Approval (PMA) is the FDA's most stringent review pathway, required for Class III high-risk devices. A 510(k) clearance is for moderate-risk devices shown to be substantially equivalent to an existing device. This actor covers PMA decisions; use the 510(k) actor for clearances.

What is the difference between an original approval and a supplement? The original PMA is the first approval of a device. Supplements cover later changes such as expanded indications, labeling updates, or manufacturing changes. Use originalOnly to exclude supplements, or read the isOriginal and supplementNumber fields.

A run returned 0 records. Why? The filter combination matched nothing in the source. Loosen filters (for example remove state or widen the date range). Zero-result runs are not charged.

What does decisionCode OK30 mean? OK30 means the FDA acknowledged a 30-day notice for a manufacturing or process change. APPR means approved. The decision field carries the plain-English version.

How do the AI add-ons work? Set withSummary or withClassify to true on a paid Apify account. Each enabled add-on runs one model call per record and writes its fields, charging only when it produces usable output. They are disabled for free accounts.

Is this an official FDA tool? No. This actor is independent and has no affiliation with the FDA or openFDA. It reads only data that is publicly available through the openFDA API. Use it in accordance with the openFDA terms of service.

Related scrapers

• FDA 510(k) Clearances Scraper: FDA 510(k) clearances for moderate-risk devices.
• FDA Drug & Device Recalls Scraper: FDA drug and device recall actions.
• openFDA Device Events Scraper: FDA device adverse event reports (MAUDE).
• openFDA Device Establishments Scraper: FDA device manufacturer registrations and listings.
• openFDA Food Recall & Enforcement Scraper: US FDA food recalls and enforcement actions.

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Independent tool, not affiliated with the FDA or openFDA. Accesses only publicly available openFDA data. Use in accordance with the openFDA terms of service.