fda_device_pma_approvals
Finds US FDA premarket approval (PMA) decisions for high-risk Class III devices, including supplements, by applicant and/or trade name, newest first: PMA and supplement numbers, decision, supplement type and reason, and FDA's approval statement. For regulatory affairs teams and investors tracking approvals and changes for implants, heart valves, pacemaker leads and similar devices. Source: FDA PMA database via openFDA. Complements fda_device_510k_clearances; most results for large makers are supplements (manufacturing or labelling changes), not new devices. (cost: 1 credit)
Input Schema
| Name | Required | Description | Default |
|---|---|---|---|
| limit | No | integer, optional, 1-50, number of decisions to return, default 10 | |
| device | No | string, optional (applicant or device required), trade name, e.g. "Symplicity" | |
| applicant | No | string, optional (applicant or device required), company holding the PMA, e.g. "Medtronic" |