DHHS/PHS/FDA/OCGM/Division of Contracts and Procurement Management/Contracts Operations Branch, HFA-512, 5600 Fishers Lane, Park Building, Room 3-32, Rockville, Maryland 20857

B -- GENDER DIFFERENCES IN EARLY AND LONG-TERM RESULTS OF CORONARY ANGIOPLASTY WITH THE PALMAZ/SCHATZ STENT SOL 223-95-6010 DUE 061395 POC Susan Pearlman, Contract Specialist (301) 443-0424, M. Deborah Smith-Castle, Contracting Officer, (301) 443-0424, FAX (301) 443-3651 The Food and Drug Administration (FDA) intends to award a contract with the University of Pittsburgh for a two (2) year period of performance. This contract shall recruit and enroll 500 women treated with the Palmaz/Schatz stent at one of several major medical institutions in the United States, and follow them postoperatively for one year. All data collected on the subject women shall be analyzed collaboratively with the Epidemiology Branch, Office of Surveillance and Biometrics, Center for Devices and Radiological Health and the University of Pittsburgh, New Approaches to Coronary Intervention (NACI) Registry investigators. The NACI Registry is the only central registry for these data in the United States. This notice is for information purposes only. See Numbered Note 22. (0117)

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