[Federal Register Volume 62, Number 141 (Wednesday, July 23, 1997)]
[Notices]
[Pages 39531-39532]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-19247]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97M-0256]
LaserVision Centers, Inc.; Premarket Approval of
LaserVision/VISX Excimer Laser System Model C for
Phototherapeutic Keratectomy (PTK) and 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 LaserVision Centers, Inc., St. Louis,
MO, for premarket approval, under the Federal Food, Drug, and Cosmetic
Act (the act), of the stationary LaserVision/VISX Excimer
Laser System Model C for Phototherapeutic Keratectomy (PTK) and
Photorefractive Keratectomy (PRK). The device is to be manufactured
under an agreement with VISX, Inc., Santa Clara, CA, which has
authorized LaserVision Centers, Inc., to incorporate information
contained in its approved premarket approval applications (PMA's) for
the VISX Excimer Laser System Model C for PTK and for the VISX Excimer
Laser System Model C for PRK. FDA's Center for Devices and Radiological
Health (CDRH) notified the applicant, by letter of November 15, 1996,
of the approval of the application.
DATES: Petitions for administrative review by August 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 more information
on the data which supported this application, please refer to the
summary of safety and effectiveness and labeling for the VISX Excimer
Laser System Model C for PTK (under Docket Number 96M-0486) and for the
VISX Excimer Laser System Model C for PRK (under Docket Number 97M-
0084).
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 June 3, 1996, LaserVision Centers, Inc.,
St. Louis, MO 63141, submitted to CDRH an application for premarket
approval of the stationary LaserVision/VISX Excimer Laser
System Model C for PTK and PRK. The device is a stationary excimer
laser which delivers pulses at 193 nanometers wavelength. The device is
indicated for PTK in patients 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 patients 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, (4)
irregular corneal surfaces associated with filamentary keratitis and
Salzmann's nodular degeneration, (5) residual band keratopathy after
unsuccessful ethylene-diamine-tetra-acetic-acid (EDTA) treatment, and
(6) scars subsequent to previous (not concurrent) pterygium excision.
In addition, the device is indicated for PRK for a 6.0 ablation zone in
patients who are myopic and meet all of the following criteria: (1) 1.0
to 6.0 diopters of myopia with astigmatism of < 1.0 diopters, (2)
refractive change is within + 0.5 diopter for 1 year prior to the laser
treatment, and (3) 18 years of age or older.
The application includes authorization from VISX, Inc., Santa
Clara, CA 95051-0703, to incorporate information contained in its
approved PMA's for VISX Excimer Laser System Model C for PTK and for
the VISX Excimer Laser System Model C for PRK.
In accordance with the provisions of section 515(c)(2) of the act
(21 U.S.C. 360e(c)(2)) as amended by the Safe Medical Devices Act of
1990, this PMA was not referred to the Ophthalmic Devices Panel of the
Medical Devices Advisory Committee, an FDA advisory committee, for
review and recommendation because the information in the PMA
substantially duplicates information previously reviewed by this panel.
On November 15, 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 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
[[Page 39532]]
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 the 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 August 22, 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: June 5, 1997.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 97-19247 Filed 7-22-97; 8:45 am]
BILLING CODE 4160-01-F