Monitor PMA Approvals with MCP

Pre-Market Approval (PMA) is the FDA's most stringent pathway for medical devices, required for Class III devices that support or sustain human life. Unlike 510(k) clearances, PMAs require clinical data. Tracking new PMA approvals and supplements gives you early visibility into high-impact device launches and product modifications.

Search PMA approvals by company

fda_search_pma({ "company": "Medtronic" })

Sample response:

{
  "results": [
    {
      "pma_number": "P870024",
      "supplement_number": "S325",
      "applicant": "Medtronic Inc.",
      "decision_code": "APPR",
      "product_code": "DXY",
      "generic_name": "Implantable Cardioverter Defibrillator",
      "trade_name": "Evera MRI ICD",
      "decision_date": "2025-09-12"
    },
    ...
  ],
  "pagination": { "offset": 0, "limit": 25, "total": 156 }
}

Original PMAs vs. supplements

A key distinction in PMA data: the supplement_number field. When it's empty or absent, the record is the original PMA approval. When it's present (e.g. "S325"), it's a supplement — a modification to an already-approved device.

Original PMAs are rare and high-signal: they represent entirely new Class III devices entering the market. Supplements are more common and indicate design changes, labeling updates, or new indications for existing devices.

Cross-reference by product code

fda_product_code_lookup({ "product_code": "DXY" })
fda_device_class({ "product_code": "DXY" })

These tools tell you what the product code means and its regulatory classification. Since PMA devices are Class III by definition, the device class lookup confirms the regulatory panel and specific regulation number governing the device.

Monitoring workflow

1. Run fda_search_pma periodically for target companies.
2. Compare pma_number + supplement_number against your stored set to detect new entries.
3. Flag original PMAs (no supplement number) as high-priority new product launches.
4. For supplements, check the generic_name and trade_name to understand what changed.
5. Use fda_company_full to see the applicant's broader regulatory portfolio alongside the PMA.