Definition of PMA Approval


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.
The JCDC shall dissolve and cease to exist upon the earlier of: (i) the date mutually agreed by the Parties for such dissolution and cessation or (ii) PMA Approval.
The Parties desire and intend to collaborate with respect to the development, validation and PMA Approval of the Companion Diagnostic on the terms and conditions set forth in this Agreement.
Purchaser shall be responsible for all other steps necessary to perfect the transfer of the PMA Approval under FDAs rules and procedures, including but not limited to, providing FDA with a written commitment to comply with conditions of approval applicable to the PMA Approval.
Pursuant to FDAs existing PMA transfer procedure, Novoste shall (a) file with FDA an original and a copy of a letter (on Novostes letterhead and signed by a duly authorized Person) notifying FDA that all rights in the PMA Approval have been transferred to Purchaser and take such other appropriate actions consistent with its obligations pursuant to Section 11.8, and (b) provide Purchaser with a complete copy of the PMA Approval.