ADM Tronics Files Application With FDA to Market Sonotron in US.NORTHVALE, N.J.--(BUSINESS WIRE)--Feb. 24, 1998--ADM Tronics Unlimited, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :ADMT ADMT Active Directory Migration Tool ADMT Air Dry Metric Ton ADMT Automated Data Management Tool ) has filed a Notification on Form 510K with the U.S. Food and Drug Administration seeking clearance to market its therapeutic electronic medical device, the Sonotron, to physicians and other medical professionals in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. . The Sonotron, a non-invasive device used to treat pain and edema edema (ĭdē`mə), abnormal accumulation of fluid in the body tissues or in the body cavities causing swelling or distention of the affected parts. , was developed and is manufactured by ADM See add/drop multiplexer. (language) ADM - A picture query language, extension of Sequel2. ["An Image-Oriented Database System", Y. Takao et al, in Database Techniques for Pictorial Applications, A. Blaser ed, pp. 527-538]. Tronics in its two 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. Registered Medical Device Manufacturing Facilities in New Jersey. It is currently marketed to physicians in a number of countries and is being used in clinical trials in the US. The filing follows several years of clinical testing conducted to determine the safety and efficacy of the Sonotron for its intended purpose. The studies were conducted by physicians and hospitals in the US, Japan and several other countries. This safety and efficacy data along with published papers were submitted to the FDA in support of the 510K filing. "I am confident that we will be successful with this FDA application and that Sonotron will soon be available on the US market. If we receive clearance, this will be a major turning point in the history of our company," stated Dr. Alfonso Di Mino, ADM Tronics' President and developer of the device. A determination, for clearance to market pursuant to a Notification on Form 510K, is typically made by the FDA within 90 to 120 days of submission unless, for example, additional information is requested. ADM Tronics is a technology based developer and manufacturer of a diversified line of products including medical electronic devices; water-based, non-polluting, recyclable chemical products used in food packaging, printing and related industries; and, innovative topical dermatological products. CONTACT: ADM Tronics Unlimited, Inc. Andre Di Mino, 201/767-6040 Fax: 201/784-0620 e-mail: andre@admtronics.com |
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