[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