PMA Application definition

PMA Application and/or “Premarket Approval Application” shall mean a premarket approval application under section 515(c) of the FDCA requesting the FDA’s approval to commercially sell and distribute a medical device 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.

  • What both OCA and DFS rulemaking as well as the Attorney General's enforcement actions do show is that debt collection abuses are so widespread in New York State that several agencies have identified the need, and have taken steps, to ameliorate the problems.

  • In the first quarter of fiscal 1994, the FDA notified the Company that the N-400 fetal oximeter must be submitted under the Pre-Market Approval (PMA) Application Regulations.

  • Bionix shall be responsible for filing any PMA Application supplements or amendments which may be necessary or appropriate in connection therewith.

  • As described in section 8.1, before downloading the user profile, the home network should not only make sure the user is authenticated but also verify that the requesting network is the network the user is currently visiting.Except for these requirements, this Diameter PMA Application does not introduce any new security threats.

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

  • 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.

  • 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.

  • 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.


More Definitions of PMA Application

PMA Application means Pre Market Approval application to be filed with the FDA with respect to the Product.
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PMA Application shall have the meaning set forth in the Supply Agreement.
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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. “Progress Failure Notice” shall have the meaning specified in Section 2.5(b) hereof.
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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)];

  • Planning Application means the application for [outline/full] planning permission dated [ ] bearing the Council’s reference number [ ];

  • Application Process means the online application process under which the Applicant applies for Hospitality Packages on the Webshop.

  • Completed application means an application that satisfies all of the information and other requirements of the Tariff, including any required deposit.

  • Biosimilar Application has the meaning set forth in Section 7.3.3.

  • Client Application means an application developed by Licensee that a) utilizes the Runtime Product, b) is installed fully on an end user’s machine, with all report processing local to that machine, and c) adds significant and primary functionality to the Runtime Product.

  • SAP Application(s) means all Packages (i.e. all Software and Third Party Software) licensed under the Agreement and/or SAP cloud services for which Customer has a valid subscription, excluding User Interfaces for ERP, SAP Technology Solutions and all database Packages.

  • Access Application means an application for Access Rights as described in section 3.7;

  • Patent Application means an application for patent protection for a CRADA Subject Invention with the United States Patent and Trademark Office (“U.S.P.T.O.”) or the corresponding patent-issuing authority of another nation.

  • Fee Application means an application for allowance and payment of a Fee Claim (including Claims for “substantial contribution” pursuant to section 503(b) of the Bankruptcy Code).

  • Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.

  • Account Application or “Application” shall mean the application, as may be amended from time to time, by which this Agreement is established between the Depositor (or following the death of the Depositor, the Beneficiary) and the Custodian. The statements contained therein shall be incorporated into this Agreement.

  • Biologics License Application or “BLA” means an application requesting permission from the FDA to introduce, or deliver for introduction, a biological product into interstate commerce, or any similar application or submission for marketing authorization of a product filed with a Regulatory Authority to obtain Regulatory Approval for such product in a country or group of countries.

  • Development Application means the development application identified in Item 5 of Schedule 1 and includes all plans, reports models, photomontages, material boards (as amended supplemented) submitted to the consent authority before the determination of that Development Application.

  • Initial application means the Application first provided to MFA on or before an Application Deadline to request an allocation of Tax Credits.

  • Approval Application means a BLA, NDA or similar application or submission for a Product filed with a Regulatory Authority in a country or group of countries to obtain marketing approval for a biological or pharmaceutical product in that country or group of countries.

  • Application packet means the information, documents, and fees required by the Department for the:

  • Uniform application means the current version of the national association of insurance commissioners uniform application for resident and nonresident insurance producer licensing.

  • Marketing Authorization Application or “MAA” means an application for Regulatory Approval (but excluding Pricing Approval) in any particular jurisdiction other than the U.S.

  • Creation Application means an application by a Participating Dealer for the creation and issue of Units in an Application Unit size (or whole multiples thereof) in accordance with the Operating Guidelines and the Trust Deed.

  • Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

  • Database application form means the application form required by the Hibiscus Coast Municipality to be filled in by the successful tenderer, following the award of the contract, for inclusion on the HCM database before payment is made.