PVT Product definition

PVT Product means the the Cribier-Edwards percutaneous heart valve, existing as of the Effective Date, including (i) any modifications or alterations to such valve that are made prior to the first approval by the United States Food and Drug Administration (“FDA”) of a premarket approval (“PMA”) application submitted on such valve in the Percutaneous Field of Use, (ii) any modifications or alterations that are made to such valve to adapt it for use in the Surgical Field of Use prior to the first approval by the FDA of a PMA application submitted on such valve in the Surgical Field of Use, and (iii) any modifications or alterations that are made to the FDA approved valves described in (i) and (ii) that do not require submission of a new PMA application.
Sample 1
PVT Product means the the Xxxxxxx-Xxxxxxx percutaneous heart valve, existing as of the Effective Date, including (i) any modifications or alterations to such valve that are made prior to the first approval by the United States Food and Drug Administration (“FDA”) of a premarket approval (“PMA”) application submitted on such valve in the Percutaneous Field of Use, (ii) any modifications or alterations that are made to such valve to adapt it for use in the Surgical Field of Use prior to the first approval by the FDA of a PMA application submitted on such valve in the Surgical Field of Use, and (iii) any modifications or alterations that are made to the FDA approved valves described in (i) and (ii) that do not require submission of a new PMA application.
Sample 1

Examples of PVT Product in a sentence

  • PVAL Paperless Eval PVR Policy Variation Request PVT Product Verification Testing PVT Product Verification Test QA Quality Assurance Responsible for ensuring that proper quality control/assurance procedures and processes are built into the design, development, and testing phases during the launch lifecycle QAIA QA Internal Alpha Data Domain QAL Quote Acknowledgement Letter Documents.

Related to PVT Product

  • Hemp product means the same as that term is defined in § 3.2-4112.

  • Licensed Product means a product, method or service in the Licensed Field of Use, the making, having made, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent.

  • Drug Product means a specific drug in dosage form from a known source of manufacture, whether

  • Nicotine product means a product that contains nicotine and is not any of the following:

  • Aerosol product means a pressurized spray system that dispenses product ingredients by means of a propellant contained in a product or a product's container, or by means of a mechanically induced force. “Aerosol Product” does not include “Pump Spray.”

  • New Product means the Synology-branded hardware product and Synology-branded accessories contained in the original packaging Customer bought from an authorized Synology distributor or reseller. You may see our “New Product” at Product Support Status.

  • Bundled Product means Product sold together with any other product(s) or service(s) at a single unit price, whether packaged together or separately, and which other product(s) or service(s) have material independent value from Product itself.

  • Generic Product means any pharmaceutical product that (i) is sold by a Third Party that is not an Affiliate or licensee of Buyer and (ii) (a) contains the same active pharmaceutical ingredient as the Product or (b) is categorized by the applicable Governmental Entity in a country to be therapeutically equivalent to, or interchangeable with, the Product, such that the pharmaceutical product may be substituted for the Product at the point of dispensing without any intervention by the prescribing physician in such country.

  • Product means any deliverable under the Contract, which may include commodities, services, technology or software.

  • Licensed Products means tangible materials which, in the course of manufacture, use, sale, or importation, would be within the scope of one or more claims of the Licensed Patent Rights that have not been held unpatentable, invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction.

  • Hemp products means all products made from industrial hemp,

  • Finished Product means a cannabis product in its final form to be sold at a retail premises.

  • medicinal product means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;

  • Biosimilar Product means, with respect to a Licensed Product in any country, any biosimilar product sold by a Third Party not authorized by or on behalf of Celgene, its Affiliates or Sublicensees, (a) that is a biosimilar biological product, as defined in 21 USC 379j-51 (or any successor or replacement thereof), a similar biological medicinal product, as defined in Annex I to Directive 2001/83/EC (or any successor or replacement thereof), or any similar biosimilar or generic product under the Laws of any country or jurisdiction, or (b) regarding which Regulatory Approval is obtained by referencing Regulatory Data of such Licensed Product.

  • Final Product means a product that is not used in producing other products and is built and intended for use outdoors, provided the final product has not deteriorated or has otherwise become a potential source of contaminants.

  • Marihuana-infused product means a topical formulation, tincture, beverage, edible substance, or similar product containing marihuana and other ingredients and that is intended for human consumption.

  • Cannabis product means cannabis that has undergone a process whereby the plant material has been transformed into a concentrate, including, but not limited to, concentrated cannabis, or an edible or topical product containing cannabis or concentrated cannabis and other ingredients.

  • Aerosol coating product means a pressurized coating product containing pigments or resins that dispenses product ingredients by means of a propellant, and is packaged in a disposable can for hand-held application, or for use in specialized equipment for ground traffic/marking applications.

  • Other Product means Product which an End User acquired from sources other than Integrator.

  • Diagnostic Product means any test or assay for diagnosing or detecting a disease, disorder, medical condition, or symptom.

  • Roll-on product means any antiperspirant or deodorant that dispenses active ingredients by rolling a wetted ball or wetted cylinder on the affected area.

  • Biological product means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein other than a chemically synthesized polypeptide, or analogous product, or arsphenamine or any derivative of arsphenamine or any other trivalent organic arsenic compound, applicable to the prevention, treatment, or cure of a disease or condition of human beings.

  • complex product means a product which is composed of multiple components which can be replaced permitting disassembly and re-assembly of the product.

  • Licensed producer means a person or entity licensed to produce medical cannabis.

  • Marijuana product means marijuana as defined in 50-32-101 and marijuana-infused products

  • Collaboration Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.