[Federal Register Volume 61, Number 247 (Monday, December 23, 1996)]
[Notices]
[Page 67559]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-32429]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96M-0486]
VISX, Inc.; Premarket Approval of VISX Excimer Laser System
(Models B and C) for Phototherapeutic Keratectomy
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., of 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). After
reviewing the recommendation of the Ophthalmic Devices Panel, FDA's
Center for Devices and Radiological Health (CDRH) notified the
applicant, by letter of September 29, 1995, of the approval of the
application.
DATES: Petitions for administrative review by January 22, 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: Morris Waxler, Center for Devices and
Radiological Health (HFZ-460), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-2018.
SUPPLEMENTARY INFORMATION: On December 24, 1991, 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 VISX
Excimer Laser System delivers pulses at 193 nanometers wavelength. The
device is indicated for phototherapeutic keratectomy (PTK) in subjects
with decreased best corrected visual acuity and/or with disabling pain
that are the result of superficial corneal epithelial irregularities or
stromal scars in the anterior one-third of the cornea. The subjects
must have failed with alternative treatment options. For safety, the
immediate postoperative corneal thickness must not be less than 250
microns.
Examples of those conditions that warrant PTK are:(1) Corneal scars
and opacity (from trauma and inactive infections); (2) dystrophies
(Reis-Buckler's, granular and lattice); (3) Thygeson's superficial
keratitis, irregular corneal surfaces associated with filamentary
keratitis and Salzmann's nodular degeneration; (4) residual band
keratopathy after unsuccessful EDTA treatment, and; (5) scars
subsequent to previous (not concurrent) pterygium excision.
On March 21, 1994, the Ophthalmic Devices Panel of the Medical
Devices Advisory Committee, an FDA advisory committee, reviewed and
recommended approval of the application. On September 29, 1995, 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 (21
U.S.C. 360e(g)), 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
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 Sec. 10.33(b) (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 (insert date 30 days
after date of publication in the Federal Register), 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: October 24, 1996.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 96-32429 Filed 12-20-96; 8:45 am]
BILLING CODE 4160-01-F
