`fda_device_pma_search`

Pack: fda-devices · Connect: https://pipeworx.io/mcp (see Connect below for a single-pack URL)

No MCP client? Call it directly: GET https://gateway.pipeworx.io/v1/tools/fda_device_pma_search for the schema, then POST the same URL with its arguments for the data.

Search FDA Premarket Approval (PMA) decisions and supplements by trade/generic name, applicant, product code, PMA number, or CLINICAL INDICATION/condition text (via indication). Which diagnostic tests are FDA-approved: covers high-risk IN VITRO DIAGNOSTIC (IVD) tests approved via PMA, including companion diagnostics and molecular residual disease (MRD) / ctDNA monitoring tests (e.g. Signatera, Guardant360 CDx) — these are FDA-approved tests, not cleared devices, so this tool (not 510(k)) is the one that finds them. indication matches free text in FDA’s own published approval-order narrative (ao_statement) — the intended-use/indication language FDA wrote when it approved the device — so a caller who describes what a test DOES or what condition/biomarker it monitors (without knowing any brand name) can still find it; device only matches the trade/generic NAME field and returns nothing for a condition-only question. Supplements may represent manufacturing or labeling changes rather than new devices, so a supplement’s own ao_statement can be a narrow procedural note (e.g. “approval of a post-approval study protocol”) rather than the full clinical indication — pass several synonymous indication phrases (FDA’s exact wording varies by product and rarely matches a lay term) rather than one exact phrase.

Parameters

Name	Type	Required	Description
`device`	string	no	Trade or generic device name substring.
`indication`	array	no	One or more clinical indication / intended-use / condition phrases, OR’d together, matched as exact phrases against the FDA approval-order narrative text (ao_statement) — NOT the device name. Use this instead of (or with) `device` when the caller names a condition/biomarker/what-it-monitors rather than a brand, e.g. for “MRD or ctDNA monitoring in solid tumors” pass [“circulating tumor DNA”,“molecular residual disease”,“minimal residual disease”,“cell-free DNA”,“ctDNA”,“MRD”] — FDA’s actual wording varies by product (Guardant360 CDx’s approval says “cell-free DNA (cfDNA)”, never “ctDNA”), so pass several synonyms rather than one exact phrase; each phrase is matched literally (no stemming/tokenizing), so an overly narrow or misspelled phrase silently finds nothing.
`items`	string	no
`applicant`	string	no	Applicant/company substring.
`product_code`	string	no	Exact FDA product code.
`pma_number`	string	no	Exact PMA number, optionally including supplement suffix.
`from_date`	string	no	Earliest decision date, YYYY-MM-DD.
`to_date`	string	no	Latest decision date, YYYY-MM-DD.
`limit`	number	no	Results (1-100, default 20).

Example call

Arguments

{
  "applicant": "Medtronic",
  "from_date": "2025-01-01",
  "limit": 10
}

curl

curl -X POST https://gateway.pipeworx.io/fda-devices/mcp \
  -H 'Content-Type: application/json' \
  -d '{"jsonrpc":"2.0","id":1,"method":"tools/call","params":{"name":"fda_device_pma_search","arguments":{"applicant":"Medtronic","from_date":"2025-01-01","limit":10}}}'

TypeScript (@pipeworx/sdk)

import { Pipeworx } from '@pipeworx/sdk';
const pipeworx = new Pipeworx();

const result = await pipeworx.call('fda_device_pma_search', {
  "applicant": "Medtronic",
  "from_date": "2025-01-01",
  "limit": 10
});

More examples

{
  "indication": [
    "circulating tumor DNA",
    "molecular residual disease",
    "minimal residual disease",
    "cell-free DNA",
    "ctDNA",
    "MRD"
  ]
}

Connect

Add this to your MCP client config — every tool in the catalog, including this one — or use one-click install buttons:

{
  "mcpServers": {
    "pipeworx": {
      "url": "https://pipeworx.io/mcp"
    }
  }
}

Connect to just the fda-devices pack

{
  "mcpServers": {
    "fda-devices": {
      "url": "https://gateway.pipeworx.io/fda-devices/mcp"
    }
  }
}

See Getting Started for client-specific install steps.

fda_device_pma_search