Urogynecologic Surgical Mesh definition

Urogynecologic Surgical Mesh means any medical device cleared or approved by the FDA (as the term “device” is defined in 21 U.S.C. § 321(h)) that contains synthetic, multi- strand, knitted, or woven mesh and that is indicated to be used for implantation in the pelvic floor to treat stress urinary incontinence (SUI) and/or pelvic organ prolapse (POP) sold or marketed in the United States.
Sample 1Sample 2Sample 3
Urogynecologic Surgical Mesh means any medical device cleared or approved
Sample 1Sample 2Sample 3

Examples of Urogynecologic Surgical Mesh in a sentence

  • BARD shall evaluate emerging risk information on an ongoing basis and, consistent with such risk information, shall update the warnings and precautions section of IFUs and all Marketing Material to include Significant Complications associated with its Urogynecologic Surgical Mesh products as soon as practicable.

  • However, for Post-Effective Date Urogynecologic Surgical Mesh, BARD may represent or imply that such Urogynecologic Surgical Mesh does not cause a foreign body reaction, including any chronic foreign body reaction, after the Urogynecologic Surgical Mesh is implanted inside the body, if such statement is supported by Valid Scientific Evidence.3.10.

  • BARD shall not, in any Marketing Materials, misrepresent the FDA approval or clearance status of its Urogynecologic Surgical Mesh devices or the extent to which any of its Urogynecologic Surgical Mesh products have been studied or clinically proven.3.13.

  • In accordance with applicable law, BARD shall register BARD-sponsored clinical studies regarding its Urogynecologic Surgical Mesh with ClinicalTrials.gov.

  • BARD shall not, in any Marketing Materials, represent or imply that such Urogynecologic Surgical Mesh is “soft” or that it has “multidirectional elasticity” within the body after implantation or use any other phrases having an equivalent meaning.

  • This webinar should be conducted in the middle of the semester when interns understand the terminology and have a better sense of their future career goals and choices.

  • The audits are to be performed in accordance with the provisions contained in this request for proposals, all applicable state and federal laws and regulations and all applicable accounting standards including GASB as the same may be amended from time to time.

  • BARD shall not, in any Marketing Materials, represent or imply that such Urogynecologic Surgical Mesh, including its collagen Urogynecologic Surgical Mesh, helps the body more readily accept a foreign body implant, or reduces the risk of foreign body reaction, erosion, infection, or any other Urogynecologic Surgical Mesh complications, including any Significant Complications or Inherent Complications.

  • BARD shall, in the marketing and promotion of any Urogynecologic Surgical Mesh product, ensure that its Marketing Materials and other communications do not misrepresent FDA updates or communications regarding Urogynecologic Surgical Mesh.

  • BARD shall not cite to any clinical study, clinical data, or preclinical data regarding Urogynecologic Surgical Mesh for which any author/consultant, to the extent BARD knows, has not complied with the applicable publication’s conflict disclosure requirements unless BARD discloses the conflict in a clear and conspicuous manner when citing to such study or data.3.23.

Related to Urogynecologic Surgical Mesh

  • Ambulatory surgical center means any public or private State licensed and approved (whenever required by law) establishment with an organized medical staff of Physicians, with permanent facilities that are equipped and operated primarily for the purpose of performing Surgical Procedures, with continuous Physician services and registered professional nursing service whenever a patient is in the facility, and which does not provide service or other accommodations for patients to stay overnight.

  • Medical cannabis pharmacy means the same as that term is defined in Section 26-61a-102.

  • Drug therapy management means the review of a drug therapy regimen of a patient by one or more pharmacists for the purpose of evaluating and rendering advice to one or more practitioners regarding adjustment of the regimen.

  • Radiologic technologist, limited means an individual, other than a licensed radiologic technologist,

  • Medical cannabis means the same as that term is defined in Section 26-61a-102.

  • Clean coal technology means any technology, including technologies applied at the precombustion, combustion, or post combustion stage, at a new or existing facility which will achieve significant reductions in air emissions of sulfur dioxide or oxides of nitrogen associated with the utilization of coal in the generation of electricity, or process steam which was not in widespread use as of November 15, 1990.

  • Modern biotechnology means the application of:

  • Ambulatory surgical facility means a facility that:

  • Naturopathic physician means a person licensed to practice naturopathic medicine by the Oregon Board of Naturopathic Medicine.

  • Brachytherapy source means a radioactive source or a manufacturer-assembled source train or a combination of these sources that is designed to deliver a therapeutic dose within a distance of a few centimeters.

  • veterinary surgeon means a veterinary surgeon within the meaning of the Veterinary Surgeons Act 1936.

  • Physical therapy licensing board or "licensing board" means the agency of a state that is responsible for the licensing and regulation of physical therapists and physical therapist assistants.

  • Medical cannabis card means the same as that term is defined in Section 26-61a-102.

  • Practice of medicine or osteopathic medicine means the prevention, diagnosis and treatment of

  • Dialysis solution means either the commercially available, unopened, sterile solutions whose

  • Cosmetology means the art or practice of embellishment, cleansing, beautification, and styling of hair, wigs, postiches, face, body, or nails.

  • Clean coal technology demonstration project means a project using funds appropriated under the heading “Department of Energy—Clean Coal Technology,” up to a total amount of $2,500,000,000 for commercial demonstration of clean coal technology, or similar projects funded through appropriations for the Environmental Protection Agency. The federal contribution for a qualifying project shall be at least 20 percent of the total cost of the demonstration project.

  • cannabis resin means the separated resin, whether crude or purified, obtained from any plant of the genus Cannabis;

  • Microenterprise means an enterprise which employs fewer than 10 persons and whose annual turnover and/or annual balance sheet total does not exceed EUR 2 million;

  • coronavirus means severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2);

  • Radiologic technologist means an individual, other than a licensed doctor of medicine, osteopathy,

  • LHSIA means the Local Health System Integration Act, 2006, and the regulations made under it, as it and they may be amended from time to time;

  • Cannabis wholesaler means any licensed person or entity that purchases or otherwise obtains, stores, sells or otherwise transfers, and may transport, cannabis items for the purpose of resale or other transfer to either another cannabis wholesaler or to a cannabis retailer, but not to consumers.

  • Non-Administrator Ambulatory Surgical Facility means an Ambulatory Surgical Facility which does not meet the definition of an Administrator Ambulatory Surgical Facility.

  • Nuclear medicine technologist means an individual who holds a current certification with the American Registry of Radiological Technologists or the Nuclear Medicine Technology Certification Board.

  • Gamete means either of the two generative cells essential for human reproduction;