-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: keymaster@town.hall.org Originator-Key-Asymmetric: MFkwCgYEVQgBAQICAgADSwAwSAJBALeWW4xDV4i7+b6+UyPn5RtObb1cJ7VkACDq pKb9/DClgTKIm08lCfoilvi9Wl4SODbR1+1waHhiGmeZO8OdgLUCAwEAAQ== MIC-Info: RSA-MD5,RSA, SDoRNtxFFLnEGJ5LE2Mrz/vsT6foDQ3MFoK19VPrnRjiPNtK3S2GlAjCaHU+7ptd R8fjAC65v03NijWspIk4Qw== 0000009892-95-000013.txt : 199507070000009892-95-000013.hdr.sgml : 19950707 ACCESSION NUMBER: 0000009892-95-000013 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 19950706 ITEM INFORMATION: Acquisition or disposition of assets FILED AS OF DATE: 19950706 SROS: NYSE FILER: COMPANY DATA: COMPANY CONFORMED NAME: BARD C R INC /NJ/ CENTRAL INDEX KEY: 0000009892 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 221454160 STATE OF INCORPORATION: NJ FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-06926 FILM NUMBER: 95552367 BUSINESS ADDRESS: STREET 1: 730 CENTRAL AVE CITY: MURRAY HILL STATE: NJ ZIP: 07974 BUSINESS PHONE: 9082778000 MAIL ADDRESS: STREET 1: 730 CENTRAL AVENUE CITY: MURRAY HILL STATE: NJ ZIP: 07974 8-K 1 SEC 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) 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 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. # # # # # # -----END PRIVACY-ENHANCED MESSAGE-----