[Federal Register Volume 60, Number 161 (Monday, August 21, 1995)]
[Notices]
[Pages 43473-43474]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-20685]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration


Advisory Committee Meeting; Amendment of Notice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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[[Page 43474]]


SUMMARY: The Food and Drug Administration (FDA) is announcing an 
amendment to the notice of a meeting of the Circulatory System Devices 
Panel of the Medical Devices Advisory Committee, which is scheduled for 
August 21 and 22, 1995. This meeting was announced in the Federal 
Register of July 21, 1995 (60 FR 37655 at 37656). The amendment is 
being made to reflect a change in the meeting from a 2-day to a 1-day 
meeting, to announce a change in the starting time from 8:30 a.m. to 
7:30 a.m., to make a change in the agenda for the meeting. The 
committee will still be provided with closed presentation of data as 
originally planned. The meeting place remains the same. This amendment 
will be announced at the beginning of the open portion of the meeting.

FOR FURTHER INFORMATION CONTACT:  Ramiah Subramanian, Center for 
Devices and Radiological Health (HFZ-450), Food and Drug 
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-
8320.

SUPPLEMENTARY INFORMATION: In the Federal Register of July 21, 1995, 
FDA announced that a meeting of the Circulatory System Devices Panel of 
the Medical Devices Advisory Committee would be held on August 21 and 
22, 1995. On page 37656, in the second column, the ``Date, time, and 
place'' portion is amended, and in the third column, the ``Type of 
meeting and contact person'' and ``Open committee discussion'' portions 
are amended to read as follows:
    Date, time, and place. August 21, 1995, 7:30 a.m., Holiday Inn--
Gaithersburg, Ballroom, Two Montgomery Village Ave., Gaithersburg, MD.
    Type of meeting and contact person. Closed presentation of data, 
7:30 a.m. to 8:30 a.m.; open public hearing, 8:30 a.m. to 9:30 a.m., 
unless public participation does not last that long; open committee 
discussion, 9:30 a.m. to 4:30 p.m.; Ramiah Subramanian, Center for 
Devices and Radiological Health (HFZ-450), Food and Drug 
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-
8320, or FDA Advisory Committee Information Hotline, 1-800-741-8138 
(301-443-0572 in the Washington, DC area), Circulatory System Devices 
Panel, code 12625.
    Open committee discussion. The committee will discuss general 
issues related to a premarket approval application (PMA) for an 
automatic cardioverter defibrillator and will review and recommend the 
reclassification status of nonroller type cardiopulmonary bypass blood 
pumps (i.e., centrifugal pump) for short-term (6 hours or less) use.

    Dated: August 15, 1995.
Linda A. Suydam,
Interim Deputy Commissioner for Operations.
[FR Doc. 95-20685 Filed 8-16-95; 4:17 pm]
BILLING CODE 4160-01-F