fda_device_pma
Search FDA Premarket Approval decisions for Class III medical devices to verify safety and effectiveness approvals. Filter by decision code, product code, applicant, or advisory committee.
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 |
|---|---|---|---|
| limit | No | Max results (default 10, max 100) | |
| search | No | OpenFDA search query. Examples: 'field:value', 'field:"Exact Phrase"', 'field:[20200101+TO+20231231]', '_exists_:field'. Combine with '+AND+', '+OR+', '+NOT+'. |