[Federal Register Volume 63, Number 123 (Friday, June 26, 1998)]
[Notices]
[Page 34902]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-17075]



[[Page 34902]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Ophthalmic Devices Panel of the Medical Devices Advisory 
Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). The meeting will 
be open to the public.
    Name of Committee: Ophthalmic Devices Panel of the Medical Devices 
Advisory Committee.
    General Function of the Committee: To provide advice and 
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on July 23, 1998, 8 a.m. to 
5 p.m.
    Location: Holiday Inn, Ballroom, Two Montgomery Village Ave., 
Gaithersburg, MD.
    Contact Person: Sara M. Thornton, Center for Devices and 
Radiological Health (HFZ-460), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), code 12396. Please call the Information Line for up-to-date 
information on this meeting.
    Agenda: The committee will discuss: (1) Premarket approval 
application (PMA) for a toric intraocular lens for primary implantation 
for the visual correction of aphakia, and (2) PMA for an excimer laser 
for the surgical correction of hyperopia, sphere only, using 
photorefractive keratectomy.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
Written submissions may be made to the contact person by July 15, 1998. 
Oral presentations from the public will be scheduled between 
approximately 8:30 a.m. and 9 a.m. An additional 30-minute time period 
will be given for public comment at the end of committee discussion and 
prior to voting on each PMA. Time allotted for each presentation may be 
limited. Those desiring to make formal oral presentations should notify 
the contact person before July 12, 1998, and submit a brief statement 
of the general nature of the evidence or arguments they wish to 
present, the names and addresses of proposed participants, and an 
indication of the approximate time requested to make their 
presentation.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).
    Dated: June 18, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-17075 Filed 6-25-98; 8:45 am]
BILLING CODE 4160-01-F