Biopsys Medical Resolves Labeling Issues with FDA.IRVINE, Calif.--(BW HealthWire)--Feb. 24, 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 received confirmation 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. ) that all issues set out in a Feb. 5, 1997 warning letter concerning the labeling and promotion of the company's Mammotome(R) Biopsy System have been satisfactorily resolved. As part of the resolution, and consistent with the agency's efforts to create consistent labeling for all breast biopsy Breast Biopsy Definition A breast biopsy is removal of breast tissue for examination by a pathologist. This can be accomplished surgically, or by withdrawing tissue through a needle. devices, the company submitted on Feb. 12, 1997 a new 510(k) premarket notification for the Mammotome, which is specifically directed towards breast biopsy for diagnostic purposes. This premarket notification is currently under review by the agency. "We are happy to have promptly resolved all the issues identified in the agency's warning letter, and we fully support the agency's efforts to create consistent labeling for all breast biopsy devices," stated Steven L. Gex, president and chief executive officer of Biopsys. Discussions in this news release may contain forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. that involve risks and uncertainties including, but not limited to, the uncertainties associated with the FDA regulatory process. Biopsys Medical Inc. is a leading developer, manufacturer and marketer of diagnostic devices for biopsy. CONTACT: Biopsys Medical Inc. Steve Naber, 714/460-7800 or Morgen-Walke Associates Inc. Doug Sherk or John Swenson, 415/296-7383 Joshua Passman or Emily Dupree, 212/850-5600 |
|
||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion