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premarket approval

См. также в других словарях:

  • Premarket approval — (PMA) ist ein Prozess der amerikanischen Gesundheitsbehörde FDA zur wissenschaftlichen und regulierenden Überprüfung von medizinische Geräten der Klasse III, um deren Sicherheit und Wirksamkeit zu beurteilen. Klasse III Geräte sind jene, die das… …   Deutsch Wikipedia

  • Food and Drug Administration — FDA redirects here. For other uses, see FDA (disambiguation). Food and Drug Administration Agency overview Formed 1906 …   Wikipedia

  • Medical device — A medical device is a product which is used for medical purposes in patients, in diagnosis, therapy or surgery[citation needed]. Whereas medicinal products (also called pharmaceuticals) achieve their principal action by pharmacological, metabolic …   Wikipedia

  • U.S. Food and Drug Administration — Infobox Government agency agency name = Food and Drug Administration parent agency = logo width = 200px logo caption = FDA Logo formed = 1906 [cite web|url=http://www.fda.gov/centennial/|title=FDA Centennial 1906 2006|accessdate=2008 09… …   Wikipedia

  • Federal Food, Drug, and Cosmetic Act — Infobox U.S. legislation name= Federal Food, Drug, and Cosmetic Act fullname= acronym= FFDCA, FD C Act enacted by= effective date= public law url= cite public law= cite statutes at large= acts amended= title amended= sections created= sections… …   Wikipedia

  • Biomedical engineering — For the Russian journal on the subject, see Meditsinskaya Tekhnika. Ultrasound representation of Urinary bladder (black butterfly like shape) and hyperplastic prostate. An example of engineering science and medical science working together …   Wikipedia

  • Riegel v. Medtronic, Inc. — Infobox SCOTUS case Litigants=Riegel v. Medtronic, Inc. ArgueDate=December 4 ArgueYear=2007 DecideDate=February 20 DecideYear=2008 FullName=Charles R. Riegel, et ux. v. Medtronic, Inc. OralArgument=http://www.oyez.org/cases/2000 2009/2007/2007 06 …   Wikipedia

  • Breathalyzer — A breathalyzer is a (breath analyser) device for estimating blood alcohol content (BAC) from a breath sample. Breathalyzer is the brand name of a series of models made by one manufacturer of these instruments (originally Smith and Wesson, later… …   Wikipedia

  • Breast implant — A breast implant is a prosthesis used to enlarge the size of a woman s breasts (known as breast augmentation, breast enlargement, mammoplasty enlargement, augmentation mammoplasty or the common slang term boob job) for cosmetic reasons; to… …   Wikipedia

  • Orthokeratology — (also referred to as Ortho K, Overnight Vision Correction and Corneal Refractive Therapy), marketed under brand names like EyeDream , MiracLens , DreamLens , i GO OVC , GOV , Wake and See , CRT and Emerald , is the use of rigid gas permeable… …   Wikipedia

  • Center for Devices and Radiological Health — The Center for Devices and Radiological Health (CDRH) is the branch of the United States Food and Drug Administration responsible for the premarket approval of all medical devices, as well as overseeing the manufacturing, performance and safety… …   Wikipedia

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