[Federal Register Volume 62, Number 57 (Tuesday, March 25, 1997)]
[Notices]
[Pages 14154-14155]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-7478]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 97M-0084]


VISX, Inc.; Premarket Approval of VISX Excimer Laser System 
(Models B and C) for Photorefractive Keratectomy (PRK)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing its 
approval of the application by VISX, Inc., Santa Clara, CA, for 
premarket approval, under the Federal Food, Drug, and Cosmetic Act (the 
act), of the VISX Excimer Laser System (Models B and C) for PRK. After 
reviewing the recommendation of the Ophthalmic Devices Panel, FDA's 
Center for Devices and Radiological Health (CDRH) notified the 
applicant, by letter of March 27, 1996, of the approval of the 
application.

DATES: Petitions for administrative review by April 24, 1997.

ADDRESSES: Written requests for copies of the summary of safety and 
effectiveness data and petitions for administrative review to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Jan C. Callaway, Center for Devices 
and Radiological Health (HFZ-460), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-2018.

SUPPLEMENTARY INFORMATION: On June 15, 1996, VISX, Inc., Santa Clara, 
CA 95051, submitted to CDRH an application for premarket approval of 
the VISX Excimer Laser System (Models B and C). The device is an argon

[[Page 14155]]

fluoride excimer laser and is indicated for PRK treatments: (1) For the 
reduction or elimination of mild to moderate myopia (nearsightedness) 
of between -1.0 to -6.0 diopters spherical equivalent at the corneal 
plane, in patients with less than or equal to 1.0 diopters of 
astigmatism; (2) in patients with documented evidence of a change in 
manifest refraction of less than or equal to 0.50 diopters (in both 
cylinder and sphere components) per year for at least 1 year prior to 
the date of preoperative examination; and (3) in patients who are 18 
years of age or older.
    On October 20, 1995, the Ophthalmic Devices Panel of the Medical 
Devices Advisory Committee, an FDA advisory committee, reviewed and 
recommended conditional approval of the application. On March 27, 1996, 
CDRH approved the application by a letter to the applicant from the 
Director of the Office of Device Evaluation, CDRH.
    A summary of the safety and effectiveness data on which CDRH based 
its approval is on file in the Dockets Management Branch (address 
above) and is available from that office upon written request. Requests 
should be identified with the name of the device and the docket number 
found in brackets in the heading of this document.

Opportunity for Administrative Review

    Section 515(d)(3) of the act (21 U.S.C. 360e(d)(3)) authorizes any 
interested person to petition, under section 515(g) of the act, for 
administrative review of CDRH's decision to approve this application. A 
petitioner may request either a formal hearing under 21 CFR part 12 of 
FDA's administrative practices and procedures regulations or a review 
of the application and CDRH's action by an independent advisory 
committee of experts. A petition is to be in the form of a petition for 
reconsideration under 21 CFR 10.33(b). A petitioner shall identify the 
form of review requested (hearing or independent advisory committee) 
and shall submit with the petition supporting data and information 
showing that there is a genuine and substantial issue of material fact 
for resolution through administrative review. After reviewing the 
petition, FDA will decide whether to grant or deny the petition and 
will publish a notice of its decision in the Federal Register. If FDA 
grants the petition, the notice will state the issue to be reviewed, 
the form of review to be used, the persons who may participate in the 
review, the time and place where the review will occur, and other 
details.
    Petitioners may, at any time on or before April 24, 1997, file with 
the Dockets Management Branch (address above) two copies of each 
petition and supporting data and information, identified with the name 
of the device and the docket number found in brackets in the heading of 
this document. Received petitions may be seen in the office above 
between 9 a.m. and 4 p.m., Monday through Friday.
    This notice is issued under the Federal Food, Drug, and Cosmetic 
Act (secs. 515(d), 520(h) (21 U.S.C. 360e(d), 360j(h))) and under 
authority delegated to the Commissioner of Food and Drugs (21 CFR 5.10) 
and redelegated to the Director, Center for Devices and Radiological 
Health (21 CFR 5.53).

    Dated: February 20, 1997.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 97-7478 Filed 3-24-97; 8:45 am]
BILLING CODE 4160-01-F