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

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]

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