fda_device_pma
Search for FDA Premarket Approval (PMA) decisions on high-risk Class III medical devices to evaluate safety and effectiveness.
Instructions
Search Premarket Approval (PMA) decisions for Class III medical devices. PMA is required for high-risk devices — evaluates safety and effectiveness.
Example searches:
'decision_code:APPR' — approved PMAs
'product_code:LWP' — by product code
'advisory_committee:CV' — cardiovascular devices
'applicant:"Medtronic"' — by company
Count fields: advisory_committee, decision_code
Input Schema
| Name | Required | Description | Default |
|---|---|---|---|
| search | No | OpenFDA search query. Examples: 'field:value', 'field:"Exact Phrase"', 'field:[20200101+TO+20231231]', '_exists_:field'. Combine with '+AND+', '+OR+', '+NOT+'. | |
| limit | No | Max results (default 10, max 100) |