PMA Approval means pre-market approval in the United States, as defined in 21 U.S.C. SS360(e) of the United States Code, of a Companion Diagnostic incorporating a Program Biomarker.
Examples of PMA Approval in a sentence
If Genoptix elects to or is obligated to commercialize the Companion Diagnostic after PMA Approval has been obtained, Genoptix shall be responsible for the selection, registration, maintenance and defense of all trademarks for specific use in the commercialization of the Companion Diagnostic (the Genoptix Marks), as well as all expenses associated therewith.
PMA Approval means FDAs approval of PMA Application P000018, including all amendments, supplements and reports.
(vii) PMA Approval means U.S. Food and Drug Administration approval of a premarket approval (PMA) application.