[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