FDA Pre-Market Approval applications for Class III high-risk medical devices (life-sustaining, life-supporting, or implantable). 56k submissions including original PMAs + supplements + amendments. Each: PMA number, supplement number, generic + trade name, applicant, product code, docket number, decision code (APPR), expedited-review flag, supplement type/reason, advisory committee, approval order statement. The most rigorous FDA device pathway.
Every record in this dataset can be traced back to its primary source at https://open.fda.gov/apis/device/pma/. Underlying content is a US federal government work (public domain under 17 USC §105); our derived data is licensed CC0 1.0.