-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, Wik4RHxdIHT+ieduQFUXKLnqjvGmSCPFPIcFTa2LsPmRRsjIDY7AgN3kSZHMZaGg 6MSDC9HqkXoYvtXG1v838Q== 0000051396-97-000016.txt : 19970227 0000051396-97-000016.hdr.sgml : 19970227 ACCESSION NUMBER: 0000051396-97-000016 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 19970225 ITEM INFORMATION: Other events FILED AS OF DATE: 19970226 SROS: CSX SROS: NYSE SROS: PSE FILER: COMPANY DATA: COMPANY CONFORMED NAME: MALLINCKRODT GROUP INC CENTRAL INDEX KEY: 0000051396 STANDARD INDUSTRIAL CLASSIFICATION: IN VITRO & IN VIVO DIAGNOSTIC SUBSTANCES [2835] IRS NUMBER: 361263901 STATE OF INCORPORATION: NY FISCAL YEAR END: 0630 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-00483 FILM NUMBER: 97544452 BUSINESS ADDRESS: STREET 1: 7733 FORSYTH BLVD CITY: ST LOUIS STATE: MO ZIP: 63105-1820 BUSINESS PHONE: 3148545299 MAIL ADDRESS: STREET 1: 7733 FORSYTH BLVD CITY: ST LOUIS STATE: MO ZIP: 63105-1820 FORMER COMPANY: FORMER CONFORMED NAME: IMCERA GROUP INC DATE OF NAME CHANGE: 19920703 FORMER COMPANY: FORMER CONFORMED NAME: INTERNATIONAL MINERALS & CHEMICAL CORP DATE OF NAME CHANGE: 19900614 8-K 1 SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 February 25, 1997 Mallinckrodt Inc. (Exact name of registrant as specified in its charter) New York 1-483 36-1263901 (State or other jurisdiction (Commission (I.R.S. Employer of incorporation) File Number) Identification No.) 7733 Forsyth Boulevard, St. Louis, MO 63105-1820 (Address of principal executive offices) (ZIP Code) Registrant's telephone number, (314) 854-5200 including area code Item 5. Other Events A press release was issued February 25, 1997. The relevant portion of the text of that release was as follows. (*) Indicates registered trademark FDA ADVISORY PANEL RECOMMENDS CLEARANCE OF ALBUNEX* ULTRASOUND IMAGING AGENT FOR USE IN DIAGNOSING FALLOPIAN TUBE PATENCY ST. LOUIS, Mo., February 25, 1997 -- Mallinckrodt Inc. (NYSE:MKG) announced today that the Radiology Device Advisory Panel of the U. S. Food and Drug Administration (FDA) has voted 7-0 to recommend clearance of ALBUNEX* [albumin (human), 5%, sonicated], an ultrasound imaging agent, for use in infertility diagnosis in women. The vote came yesterday during an advisory panel meeting in Washington. The specific use voted on by the panel is for diagnosing fallopian tube patency, which refers to the extent to which the fallopian tube is open or obstructed. "We are delighted with the vote of the panel," said Neal L. Muhilly, imaging vice president-ultrasound for Mallinckrodt. "A contrast-enhanced ultrasound procedure for diagnosing fallopian tube patency offers a number of significant advantages to women. It is a minimally invasive, non-surgical option versus laparoscopy. Additionally, there would be no exposure to radiation as with an HSG exam. Finally, the contrast-enhanced ultrasound procedure can be performed in the privacy of a physician's office under the control of the woman's gynecologist or reproductive endocrinologist". ALBUNEX* is a product of Molecular Biosystems, Inc. Mallinckrodt is the marketer of the product and also has been responsible for conducting the clinical trials of ALBUNEX* for the indication of diagnosing fallopian tube patency. ALBUNEX* is the first ultrasound contrast agent cleared for use in the United States. Its current indication is for the diagnosis of cardiac disorders. Molecular Biosystems, based in San Diego, Calif., is a world leader in the development of ultrasound contrast agents for medical imaging. Its shares are listed on the New York Stock Exchange under the symbol "MB". Mallinckrodt is a dynamic, international growth company serving specialty markets in human healthcare and chemicals and is dedicated to improving healthcare and chemistry. Mallinckrodt is a major producer of analgesic pharmaceuticals, diagnostic imaging agents, medical devices, catalysts, and laboratory and microelectronic chemicals. The St. Louis-based company, with fiscal 1996 net sales of $2.2 billion, sells more than 2,000 products in more than 100 countries. Mallinckrodt employs about 10,400 people worldwide. The Mallinckrodt web site can be found at (www.mallinckrodt.com) # # # Mallinckrodt Inc. ROGER A. KELLER Vice President, Secretary and General Counsel DATE: February 25, 1997 -----END PRIVACY-ENHANCED MESSAGE-----