[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]
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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.
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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
