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.
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