PMA Submission definition

PMA Submission means a submission by Senseonics, its affiliate or sublicensee to the FDA with respect to the 180-day Eversense XL of a pre-market approval (or other equivalent approval granted by the FDA) application.
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PMA Submission means the initial filing of a PMA with the FDA or Foreign Equivalent.
Sample 1
PMA Submission means written evidence of submission of all required -------------- modules of the Company's premarket approval application to the United States Food & Drug Administration for the approval to begin commercial distribution of the Vascular Solutions Duett sealing device in the United States.
Sample 1

Examples of PMA Submission in a sentence

  • The Company shall give the ---------------------------------------- Investors notice of the occurrence of PMA Submission or PMA Approval within three (3) business days after each such occurrence.

  • The Company will update the directors as to the progress of the Company's PMA Submission to the United States Food & Drug Administration at each meeting of the Board and will respond to inquiries from members of the Board on this topic between meetings.

Related to PMA Submission

  • Regulatory Submissions means any filing, application or submission with any Regulatory Authority, including authorizations, approvals or clearances arising from the foregoing, including Regulatory Approvals and any pricing or reimbursement approvals, as applicable, and all correspondence or communication with or from the relevant Regulatory Authority, as well as minutes of any material meetings, telephone conferences or discussions with the relevant Regulatory Authority, in each case, with respect to a Licensed Product.

  • Regulatory Filing means any filing with any Governmental Authority with respect to the research, development, manufacture, distribution, pricing, reimbursement, marketing or sale of a Product.

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

  • 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.

  • Regulatory Materials means materials developed or compiled in preparation for Regulatory Authority meetings, regulatory applications, submissions, dossiers, notifications, registrations, Regulatory Approvals and/or other filings made to or with, or other approvals granted by, a Regulatory Authority that are necessary or reasonably desirable for the Development, manufacture, market, sale, or Commercialization of a Licensed Product in a particular regulatory jurisdiction.

  • 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.

  • Investigational Product means the Study Drug identified above and the control material, as further detailed in the Protocol;

  • Drug Approval Application means an application for Regulatory Approval required before commercial sale or use of a Licensed Product as a drug in a regulatory jurisdiction.

  • FDA means the United States Food and Drug Administration and any successor agency thereto.

  • Regulatory Filings means any submission to a Regulatory Authority of any appropriate regulatory application together with any related correspondence and documentation, and will include any submission to a regulatory advisory board, marketing authorization application, and any supplement or amendment thereto.

  • Clinical Study or “Clinical Studies” means a Phase 0 Xxxxx, Xxxxx 0 Xxxxx, Xxxxx 0 Trial or Phase 4 Trial, or such other study in humans that is conducted in accordance with good clinical practices and is designed to generate data in support or maintenance of an NDA, MAA or other similar marketing application.

  • Development Candidate means a Compound that meets the Development Candidate Criteria for the initiation of a Development Program for the treatment of CF, and which is the subject of a notice from Vertex to CFFT that Vertex intends to commence formal pre-clinical development of the Compound in the Field pursuant to the provisions of Section 3.1 hereof.

  • Clinical Studies means any clinical studies of a Licensed Product conducted on humans.

  • JDC has the meaning set forth in Section 3.2.

  • Product Candidate means each of MYO-101, MYO-102, MYO-103, MYO-201 and MYO-301, as defined on Exhibit B, in each case in any form or formulation.

  • IND means (a) an Investigational New Drug Application as defined in the FD&C Act and applicable regulations promulgated thereunder by the FDA, or (b) the equivalent application to the equivalent agency in any other regulatory jurisdiction, the filing of which is necessary to initiate or conduct clinical testing of a pharmaceutical product in humans in such jurisdiction.

  • Commercialization Plan has the meaning set forth in Section 6.2.

  • Program of study means a curriculum that requires a candidate to demonstrate and document competency in the specific knowledge, skills, and dispositions for a particular endorsement to an educator’s license, a licensure content area, or level of licensure, and is:

  • NDA means a New Drug Application, as defined in the regulations promulgated by the United States Food and Drug Administration, or any foreign equivalent thereof.

  • Investigational Medicinal Product means the study drug or control material as defined in the Protocol.

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

  • BLA means a Biologics License Application under the United States’ Public Health Services Act and Federal Food, Drug and Cosmetics Act, each as amended, and the regulations promulgated thereunder, or a comparable filing seeking Regulatory Approval in any country.