510(k) Clearance definition

510(k) Clearance means clearance for Commercialization of a medical device such as the Instrument by the FDA.

510(k) Clearance means the FDA’s written notification of the clearance of the 510(k) premarket notification under section 510(k) of the FDCA (21 U.S.C. Section 360(k)).

510(k) Clearance means the U.S. Food and Drug Administration’s written authorization to market a medical device pursuant to a premarket notification submitted under section 510 of the Federal Food, Drug, and Cosmetic Act.

Examples of 510(k) Clearance in a sentence

• Institute of Medicine, Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years, Washington, DC, July 2011, p.

• These reports are listed in Institute of Medicine (IOM), Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years, Washington, DC, July 2011, p.

• Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years.

• Public Health Effectiveness of the FDA 510(k) Clearance Process: Measuring Postmarket Performance and Other Select Topics: Workshop Report.

• Among our products intended for the U.S. market, the VenusP-Valve and VenusA-Valve are likely to be classified as Class III devices in the U.S. An Overview of the Premarket Notification and Premarket Approval Processes Premarket Notification (510(k) Clearance) The FDCA requires any person who wishes to market a medical device for which a premarket approval application is not required to submit a premarket notification (a 510(k)) unless exempt (e.g., Class I, 510(k)-exempt medical devices).

More Definitions of 510(k) Clearance

510(k) Clearance means the FDA cleared 510(k) Filing and all modifications, amendments or supplements thereto.

510(k) Clearance means the FDA’s written authorization to market a medical device pursuant to a premarket notification submitted under section 510 of the Federal Food, Drug, and Cosmetic Act.

510(k) Clearance means a determination from FDA that a device is substantially equivalent to another legally U.S. marketed medical device thereby authorizing the device to be marketed in the U.S.

510(k) Clearance means the FDA’s written authorization to market a medical device pursuant to a premarket notification submitted under section 510 of the Federal Food, Drug, and Cosmetic Act. 1.02 Accounting Terms and Principles. Unless otherwise specified, all accounting terms used in each Loan Document shall be interpreted, and all accounting determinations and computations thereunder (including under Section 10 and any definitions used in such calculations) shall be made, in accordance with GAAP or IFRS, as applicable. Unless otherwise expressly provided, all financial covenants and defined financial terms shall be computed on aconsolidated basis for the Borrower and its Subsidiaries, in each case without duplication. If the Borrower requests an amendment to any provision hereof to eliminate the effect of (a) any change in GAAP or IFRS or the application thereof or (b) the issuance of any new accounting rule or guidance or in the application thereof, in each case, occurring after the date of this Agreement, then the Lenders and Borrower agree that they will negotiate in good faith amendments to the provisions of this Agreement that are directly affected by such change or issuance with the intent of having the respective positions of the Lenders and Borrower after such change or issuance conform as nearly as possible to their respective positions as of the date of this Agreement and, until any such amendments have been agreed upon, (i) the provisions in this Agreement shall be calculated as if no such change or issuance has occurred and (ii) the Borrower shall provide to the Lenders a written reconciliation in form and detail reasonably satisfactory to the Lenders, between calculations of any baskets and other requirements hereunder before and after giving effect to such change or issuance. 1.03 Interpretation. For all purposes of this Agreement, except as otherwise expressly provided herein or unless the context otherwise requires,

510(k) Clearance means the pre-marketing process under section 510(k) of the US Federal

510(k) Clearance means the permission to market pursuant to Section 510(k) of the U.S. Food and Drug Act for the manufacture and sale of the Products in the United States.

510(k) Clearance means approval, authorization or 510(k) medical device clearance from the United States FDA for the Device or the Products.