Biopsys Medical receives FDA marketing clearance.IRVINE, Calif.--(BW HealthWire)--April 2, 1997--Biopsys Medical 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 :BIOP BIOP Baghdad International Airport BIOP Broadcast Inter-ORB Protocol BIOP Burst Idle Optical Protocol BIOP Basis of Issue Plan BIOP Bureau d'Information et d'Orientation Professionnelles (French) ) today announced that it has received 510(k) premarket notification clearance from the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. (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. ) for the Mammotome Biopsy System. The 510(k) notification was submitted on February 12, 1997, to fulfill the FDA's requests and desire to establish consistent indications and promotional materials for all breast biopsy devices. The 510(k) clearance allows Biopsys to market the Mammotome Biopsy System specifically for breast biopsy for diagnostic purposes. Steven L. Gex, president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Biopsys, said, "We are pleased to to have resolved this matter expeditiously and without any material impact on the Company's operations." Biopsys Medical, Inc. is a leading developer, manufacturer and marketer of products for the diagnosis and management of breast cancer. CONTACT: BIOPSYS MEDICAL, INC. Steve Naber, 714/460-7800 or Morgen-Walke Associates, Inc. John Swenson, Doug Sherk, 415/296-7383 Joshua Passman, David Sasso, 212/850-5600 |
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