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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
COPYRIGHT 1997 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1997, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Apr 2, 1997
Words:156
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