Premarket Notification definition

Premarket Notification means premarket 510(k) notification K140944 for the Phoenix Atherectomy System.
Sample 1Sample 2
Premarket Notification means the authority to sell a medical device in the United States granted by the FDA pursuant to 21 Code of Federal Regulations Section 807.81, as amended.
Sample 1
Premarket Notification means premarket 510(k) notification K132978 for the clinical version of the MassARRAY® System, branded under the name IMPACT Dx System, and the Factor V Leiden and Factor II genotyping assay, as the same may be amended.
Sample 1

Examples of Premarket Notification in a sentence

  • The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions.

  • The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions.

  • U.S. Food and Drug Administration 510(k) Premarket Notification Database.

  • This is known as Premarket Notification - also called PMN or 510(k).

  • U.S. Food and Drug Administration (FDA) 510(k) Premarket Notification Database.

  • More information on these devices can be found using Product Code PZR on the following FDA website: 510(k) Premarket Notification (fda.gov).

  • Submission of a Premarket Notification, pursuant to 510(k), before marketing a device.

  • The modifications described in this Premarket Notification were supported with verification and validation testing.

  • The FDA cleared the EndoRotor® under the Pre-market Notification, 510(k) program in April 2017 (K170120) for use in endoscopic procedures by a trained gastroenterologist to resect and remove residual tissue from the peripheral margins following endoscopic mucosal resection (EMR).

  • Device Modifications Requiring Premarket Notification Prior to Mar- keting.

Related to Premarket Notification

  • Drug abuse means any pattern of pathological use of drugs that causes impairment in social or occupational functioning, or that produces physiological dependency evidenced by physical tolerance or by physical symptoms when it is withdrawn.

  • Marketing Authorization Application or “MAA” means an application for Regulatory Approval in a country, territory or possession.

  • date of notification means the date on which a notice is served as contemplated in section 35 or published in the media or Provincial Gazette;

  • major non-compliance outcome notification means a notification received by a council under section 19N(3) or (4) of the Food Act 1984, or advice given to council by an authorized officer under that Act, of a deficiency that does not pose an immediate serious threat to public health but may do so if no remedial action is taken

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

  • 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.

  • 1940 Act Notification means a notification of registration of the Fund as an investment company under the 1940 Act on Form N-8A, as the 1940 Act Notification may be amended from time to time.

  • Written Notification means an electronic document (including faxes, emails, internal mail on the client terminal etc.) or an announcement on the Company's website.

  • New Drug Application or “NDA” means a new drug application filed with a Regulatory Authority (not including pricing and reimbursement approval), that is analogous to the new drug application with the United States Food and Drug Administration described in 21 C.F.R. § 314.

  • Relevant Electric Retail Regulatory Authority means an entity that has jurisdiction over and establishes prices and policies for competition for providers of retail electric service to end- customers, such as the city council for a municipal utility, the governing board of a cooperative utility, the state public utility commission or any other such entity.

  • Clearance System means the principal domestic clearance system customarily used for settling trades with respect to the Underlying as determined by the Calculation Agent acting in accordance with relevant market practice and in good faith.

  • Prescription drug order means an original or new order from a practitioner for drugs, drug-related devices or treatment for a human or animal, including orders issued through collaborative care agreements. Lawful prescriptions result from a valid practitioner-patient relationship, are intended to address a legitimate medical need, and fall within the prescribing practitioner's scope of professional practice;

  • DDA Notification has the meaning provided therefor in Section 6.13(a)(i).

  • Drug Application means a new drug application, an abbreviated drug application, or a product license application for any Product, as appropriate, as those terms are defined in the FDCA.

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

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

  • Marketing Authorization means all approvals from the relevant Regulatory Authority necessary to market and sell a Product in any country (including without limitation, all applicable pricing and governmental reimbursement approvals even if not legally required to sell Product in a country).

  • Regulatory Flood Protection Elevation means the “Base Flood Elevation” plus the “Freeboard”. In “Special Flood Hazard Areas” where Base Flood Elevations (BFEs) have been determined, this elevation shall be the BFE plus two (2) feet of freeboard. In “Special Flood Hazard Areas” where no BFE has been established, this elevation shall be at least two (2) feet above the highest adjacent grade.

  • Market Abuse means any unscrupulous behavior addressed to the Market Abuse Law of 2016 (Law 102(I)/2016) and as amended, supplemented and/or replaced from time to time.

  • Public health authority means an agency or authority of the United States, a state, a territory, a political subdivision of a state or territory, an Indian tribe, or a foreign government, or a person or entity acting under a grant of authority from or contract with such public agency, including the employees or agents of such public agency or its contractors or persons or entities to whom it has granted authority, that is responsible for public health matters as part of its official mandate.

  • Notification Date means 30 days from an Account statement date (see section 6.3).

  • Nuclear Regulatory Commission (NRC) means the U.S. Nuclear Regulatory Commission or its duly authorized representatives.

  • 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.

  • Automated drug dispensing system means a mechanical or electronic system that performs

  • Marketing Authorisation means any approval (including all applicable pricing and governmental reimbursement approvals) required from the FDA or relevant Competent Authority to market and sell a Product in a particular country.

  • Relevant Supervisory Consent means, in relation to any redemption or purchase of the Notes, any required permission of the Relevant Regulator applicable to the Company or the Relevant UK Resolution Authority (as applicable). For the avoidance of doubt, Relevant Supervisory Consent will not be required if either (i) none of the Debt Securities qualify as part of the Issuer’s regulatory capital, or own funds and eligible liabilities or loss absorbing capacity instruments, as the case may be, each pursuant to the Loss Absorption Regulations, (ii) the relevant Debt Securities are repurchased for market-making purposes in accordance with any permission given by the Relevant Regulator pursuant to the Loss Absorption Regulations within the limits prescribed in such permission or (iii) the relevant Debt Securities are being redeemed or repurchased pursuant to any general prior permission granted by the Relevant Regulator or the Relevant UK Resolution Authority (as applicable) pursuant to the Loss Absorption Regulations within the limits prescribed in such permission.