[Federal Register Volume 60, Number 129 (Thursday, July 6, 1995)]
[Notices]
[Page 35214]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-16624]



-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
Food and Drug Administration
[Docket No. 95M-0179]


Summit Technology, Inc.; Premarket Approval of Excimed 
UV200LA and SVS Apex (Formerly the OmniMed) Excimer Laser Systems

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing its 
approval of the application by Summit Technology, Inc., Waltham, MA, 
for premarket approval, under the Federal Food, Drug, and Cosmetic Act 
(the act), of the Excimed UV200LA and the SVS Apex Excimer 
Laser Systems. After addressing the concerns of the Ophthalmic Devices 
Panel, FDA's Center for Devices and Radiological Health (CDRH) notified 
the applicant, by letter on March 10, 1995, of the approval of the 
application.

DATES: Petitions for administrative review by August 7, 1995.

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, rm. 
1-23, 12420 Parklawn Dr., Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Debra Y. Lewis, Center for Devices and 
Radiological Health (HFZ-460), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-2018.

SUPPLEMENTARY INFORMATION: On February 20, 1992, Summit Technology, 
Inc., Waltham, MA 02154, submitted to CDRH an application for premarket 
approval of the Excimed UV200LA and the SVS Apex Excimer 
Laser Systems. The excimer laser in the two systems delivers pulses at 
193 nanometers wavelength. The excimer laser is indicated for use in 
the following Phototherapeutic Keratectomy procedures which treat 
superficial pathology located in the anterior 100 microns of the 
cornea, where the proposed treatment area is at least 400 microns in 
thickness, and where other less invasive treatments have failed or are 
not possible, such as contact lens intolerance. This indication is 
limited to patients with decreased visual acuity or symptoms of pain 
and discomfort of sufficient severity to cause disability for the 
patients with any of the following conditions: (1) Superficial corneal 
dystrophies (granular, lattice, and Reis-Buckler's); (2) epithelial 
basement membrane dystrophy; (3) irregular corneal surfaces (secondary 
to Salzmann's degeneration, keratoconus nodules and other irregular 
surfaces); and (4) corneal scars and opacities (post-traumatic, post-
surgical, post-infectious and secondary to pathology).
    On March 21, 1994, the Ophthalmic Devices Panel of the Medical 
Devices Advisory Committee, an FDA advisory committee, reviewed and 
recommended conditional approval of the application. The concerns of 
the panel have been adequately addressed by Summit Technology, Inc., in 
subsequent submissions to FDA. On March 10, 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, for 
administrative review of CDRH's decision to approve this application. A 
petitioner may request either a formal hearing under part 12 (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 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 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 7, 1995, 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 26, 1995.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 95-16624 Filed 7-5-95; 8:45 am]
BILLING CODE 4160-01-F