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.
Sample 1Sample 2Sample 3
PMA Application means a pre-market approval application under section 515 of the FD&C.
Sample 1Sample 2Sample 3
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.
Sample 1

Examples of PMA Application in a sentence

  • In June of 1999, the FDA approved a PMA Application that Medtronic submitted for a precursor device— the Guardian Continuous Glucose Monitoring System, which consisted of a Guardian RT sensor and an external machine that measured and recorded an individual’s glucose levels.

  • Although section 515(b) of the act does not require the agency to provide specific guidance on the contents of specific PMA’s, FDA has issued a ‘‘Draft Guidance for the Preparation of PMA Application for Silicone Inflatable (Saline) Breast Prostheses’’ in November 1994 and a revised draft guidance in January 1995 (the 1995 guidance document).

  • See PMA Application No. P980022, Summary of Safety & Effectiveness Data6; see also infra Part VII.A.1 (discussing the FDA’s “premarket approval” (“PMA”)process).

  • If this study has been or will be submitted to the US Food and Drug Administration (FDA) under an Investigational New Drug (IND), Investigational Device Exemption (IDE), or Pre-Market Approval (PMA) Application, provide the US IND/IDE number: If not applicable, enter ‘N/A’.

  • BACKGROUND INFORMATION ON THE DIRECT IMPLEMENTATION PROGRAM AND REVIEW PROCESS A.

  • Peachtree Corners East - Norcross, GA 30092Norcross, GA 30092FOR IMMEDIATE RELEASE Guided Therapeutics Provides Update on PMA Application for LuViva®Advanced Cervical Scan and Timing for Filing of CE MarkCompany to host conference call with investors on January 23 at 10 a.m. ESTNORCROSS, GA (January 20, 2012) – Guided Therapeutics, Inc.

  • It was agreed the Special Meeting would be held Tuesday, May 31, 2022 at 7:30 PM.A. Application ZB#2021-14: Application by NFI Real Estate, LLC for Preliminary Major Site Plan with Use Variance to construct a warehouse in Mansfield Township with basins,parking and associated improvements to be located in Florence Township on property located at 1091 Florence Columbus Road, Florence Township.

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

  • According to McGhan Medical Corporation’s PMA Application number P990074, which sought approval for the RTV Saline-Filled Mammary Implant, “[s]aline filled breast implants are preamendment devices and have been on the market since 1965.

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


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 permission from the FDA to market the Cervical Spine Products in the United States for approved indications.
Sample 1
PMA Application shall have the meaning set forth in the Supply Agreement.
Sample 1
PMA Application means Pre Market Approval application to be filed with the FDA with respect to the Product.
Sample 1

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 in the form and number and containing all the information required pursuant to 34 Administrative Code 9.1053 (Entity Requesting Agreement to Limit Appraised Value), that has been determined by the district and the comptroller to include all minimum requirements for consideration.

  • 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.

  • Land use application means an application required by a municipality's land use

  • 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.

  • 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 in a country, territory or possession.

  • 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.

  • Server Application means an application developed by Licensee that a) utilizes the Runtime Product, b) allows more than one user to Use the Runtime Product through any middle tier application(s), and c) adds significant and primary functionality to the Runtime Product. A Client Application installed in a Windows terminal server environment (e.g. Citrix or Microsoft Remote Desktop Platform) is a Server Application.

  • Application Program means a computer program which is intended to be executed for the purpose of performing useful work for the user of the information being processed. Application programs are developed or otherwise acquired by the user of the Hardware/Software system, but they may be supplied by the Contractor.

  • 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.