PMA Application definition

PMA Application means a premarket approval application under section 515(c) of the FDCA requesting FDA's approval to commercially sell and distribute a Licensed Product in the United States and its territories and possessions, including all information submitted with or incorporated by reference therein.
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PMA Application means a pre-market approval application under section 515 of the FD&C.
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PMA Application means the pre-market approval application submitted to the FDA pursuant to Section 515 of the Food, Drug and Cosmetic Act for the purpose of obtaining permission from the FDA to market the Cervical Spine Products in the United States for approved indications.
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Examples of PMA Application in a sentence

  • Except as set forth in Section 4.3(b), as between the Parties, QMS will be responsible for seeking Regulatory Approvals of Licensed Products in the Territory that have not heretofore been obtained, including any PMA Application, and for maintaining all Regulatory Approval of Licensed Products, in all cases at its expense, and to take all necessary steps appertaining thereto.

  • Q-Med shall appoint QMS, and QMS agrees to be appointed, as Q-Med’s local agent for purposes of the PMA Application.

  • Q-Med will prepare the PMA Application in a timely manner for the first Solesta Product in the U.S. (the “Solesta PMA”) and will consider in good faith all comments provided by QMS with respect thereto.

  • Seller and Purchaser have agreed to terminate all Weekly Payments and have agreed that Purchser shall be responsible for funding and paying any related costs associated with obtaining approval of the PMA Application, which have been previously the Seller’s responsibility.

  • As used herein, the “Principal Obligations” shall be the obligations of Seller under the Agreement, as amended by this Amendment, and all actions deemed necessary or appropriate by Servicer to be taken by Seller in the prosecution of Seller’s PMA Application, including signing and delivering documents and instruments, making presentations and effecting other submissions to the FDA, United States Customs and other regulatory agencies.

  • Seller and Purchaser have agreed that Seller will engage Servicer to assist Seller in obtaining approval of Seller’s PMA Application in accordance with the terms of this Amendment.

  • CVD will cease to distribute CVD Focus products which were approved under Endosonics' PMA following approval by the FDA of CVD's original PMA Application, or twelve (12) months after execution of this Agreement, whichever occurs first.

  • The Operations shall specifically include all operations, asset administration, expenditures, and other actions in connection with the prosecution of Seller’s PMA Application.

  • Q-Med shall use commercially reasonable efforts to ensure that any such PMA Application is accepted for filing.

  • Products manufactured by MIP shall be of high quality workmanship and materials with strict adherence to the designs, drawings and materials specifications filed with the FDA as part of the PMA Application, unless approved in writing by Bionix.


More Definitions of PMA Application

PMA Application means the pre-market approval application submitted to the FDA pursuant to Section 515 of the Food, Drug and Cosmetic Act for the purpose of obtaining
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PMA Application shall have the meaning set forth in the Supply Agreement.
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PMA Application means Pre Market Approval application to be filed with the FDA with respect to the Product.
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Related to PMA Application

  • Licensed Application means an Application that (a) meets and complies with all of the Documentation and Program Requirements, and (b) has been selected and digitally signed by Apple for distribution, and includes any additional permitted functionality, content or services provided by You from within an Application using the In-App Purchase API.

  • Mobile Application means a specialized software program downloaded onto a wireless communication device.

  • Project Application means the federal Section 5311 operating assistance project application submitted by the Municipal Corporation to, and as approved by the Commissioner for the Project described in Appendix C of this Agreement, including all project supporting information submitted therewith.

  • L/C Application means an application and agreement for the issuance or amendment of a Letter of Credit in the form from time to time in use by the L/C Issuer.

  • Software Application means a digital product or service as defined in Article 2, point 13, of Regulation (EU) …/… [on contestable and fair markets in the digital sector (Digital Markets Act)];