NuTech/Division of Kinetic Concepts.NuTech/Division of Kinetic Concepts, San Antonio San Antonio (săn ăntō`nēō, əntōn`), city (1990 pop. 935,933), seat of Bexar co., S central Tex., at the source of the San Antonio River; inc. 1837. , TX, Jan. 27 (CDRH-OC). An ad in "Ostomy/Wound Management" and materials on the firm's Web site contained claims that, according to according to prep. 1. As stated or indicated by; on the authority of: according to historians. 2. In keeping with: according to instructions. 3. FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. , overstepped the 510(k)s for Biafine Wound Dressing and VacPlus Powered Suction Pump (also known as V.A.C. Therapy), produced by Laboratoire Medix, France, and distributed by NuTech. The agency objected to implications of accelerated healing and requested data supporting claims of macrophage macrophage /mac·ro·phage/ (mak´ro-faj) any of the large, mononuclear, highly phagocytic cells derived from monocytes that occur in the walls of blood vessels (adventitial cells) and in loose connective tissue (histiocytes, phagocytic recruitment, enhanced epithelial migration and reduced bacterial colonization. |
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