FDA Responds to Biocontrol's Diasensor Modular Submission.PITTSBURGH--(BUSINESS WIRE)--Sept. 16, 1999-- Biocontrol bi·o·con·trol n. See biological control. biocontrol See biological control. Technology, Inc. (OTC OTC See: Over-the-counter. OTC See over-the-counter market (OTC). BB:BICO BICO Bicolor ) announced today that the U.S. Food and Drug Administration(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. ) has responded to the first module in its Modular PMA PMA (papillary-marginal-attached), n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation. PMA Progressive muscular atrophy submission for the Diasensor 2000 Noninvasive Glucose Monitor. The module, which is centered on the manufacturing process, was submitted to the FDA for review in May of this year. The Company said that it has answered the FDA's requests in its recent response and is working closely with the agency to satisfy the FDA's requirements for approval of the module. The FDA recently implemented the modular PMA submittal process which allows medical device manufacturers to submit application information for market approval one segment at a time. Biocontrol will submit additional information in subsequent modules to complete its PMA submission, which will include clinical and nonclinical testing of its Diasensor monitor. The Company further announced that the FDA has scheduled a meeting with Biocontrol in early October. Biocontrol Technology has its corporate offices in Pittsburgh, PA and is involved in the development and manufacture of biomedical bi·o·med·i·cal adj. 1. Of or relating to biomedicine. 2. Of, relating to, or involving biological, medical, and physical sciences. devices and environmental products. Subsidiary, Diasensor.com, Inc., also located in Pittsburgh owns the patent, marketing and distribution rights to the sensor while Biocontrols has the exclusive rights to the research and development and manufacturing of the sensor. This press release contains statements of a forward looking nature. Shareholders and potential investors are cautioned that such statements are predictions and actual events or results may vary significantly. WEBSITE: www.bico.com Investor Relations Newsline Number: 1-800-357-6204 |
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