[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]
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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.
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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
