SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
DATE OF REPORT: JULY 6, 1995
C. R. BARD, INC.
(EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER)
New Jersey 1-6926 22-1454160
(STATE OF COMMISSION FILE NUMBER IRS EMPLOYER
INCORPORATION) IDENTIFICATION NO.
730 Central Avenue, Murray Hill, New Jersey
(ADDRESS OF PRINCIPAL EXECUTIVE OFFICES)
07974
(ZIP CODE)
(908) 277-8000
(REGISTRANT'S TELEPHONE NUMBER)
<PAGE>
Item 5. Other Events
In a news release dated June 30, 1995, C. R. Bard, Inc.
announced that the FDA has lifted the Applications Integrity Policy
(AIP) imposed on Bard's USCI division in January 1994. The news
release, issued by C. R. Bard, Inc. on June 30 1995, is
incorporated herein by reference, and is attached hereto as
Exhibit 1.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of
1934, the registrant has duly caused this report to be signed on
its behalf by the undersigned, thereunto duly authorized.
C. R. BARD, INC.
(Registrant)
By: William C. Bopp /s/
William C. Bopp
Senior Vice President
and Chief Financial Officer
Dated: July 6, 1995
<PAGE>
PRESS RELEASE C. R. BARD, INC.
730 CENTRAL AVENUE
MURRAY HILL, NJ 07974
EXHIBIT 1
Contact: E. L. Parker
Vice President and Treasurer
(908) 277-8059
BARD ANNOUNCES RESOLUTION WITH FDA OF APPLICATIONS
INTEGRITY POLICY (AIP) FOR USCI DIVISION
MURRAY HILL, NJ - June 30, 1995 - C. R. Bard, Inc. (NYSE-BCR) today
announced that the FDA has lifted the Applications Integrity Policy
(AIP) imposed on Bard's USCI division in January 1994. With this
lifting, the FDA will now begin reviewing USCI's pre-market
approval and 510(k) applications.
The AIP was imposed on USCI following the plea agreement entered
into by the company in October 1993 in connection with charges
stemming from violations of the Federal Food, Drug and Cosmetic Act
and other statutes. Under the AIP, all USCI pending product
applications were audited by outside consultants hired by Bard and
approved by the FDA. The company had to demonstrate to the FDA
that it is capable of compiling and submitting product applications
that are complete, based on sound science, and that fully document
the safety and efficacy of its products.
William H. Longfield, Bard's president and CEO, said, "USCI was the
subject of a most rigorous, demanding audit process. This process
has taught us a great deal, and Bard has made substantial
improvements as a result. Achieving this crucial goal required
internal teamwork, focused cooperation with the FDA and continued
dedication to Bard's fundamental principles of 'Quality, Integrity
and Service.' From the start, Bard demonstrated its willingness to
comply, its willingness to improve its processes and its
willingness to commit the necessary resources to meet FDA
expectations. The lifting of the AIP could not have been
accomplished without the hard work of many dedicated Bard employees
and the guidance of the FDA."
During the AIP, Bard has continued to develop and market
angioplasty and angiography products for markets outside the USA.
USCI intends to immediately begin submitting both new 510(k) and
PMA supplement applications for these and other products to the
FDA. Bard hopes to begin receiving 510(k) approvals on new USCI
applications late in 1995, with new PMA supplement approvals
beginning sometime in 1996.
C. R. Bard, Inc., headquartered in Murray Hill, NJ, is a leading
multinational developer, manufacturer and marketer of health care
products.
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