[Federal Register Volume 61, Number 159 (Thursday, August 15, 1996)]
[Notices]
[Pages 42428-42429]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-20855]


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[[Page 42429]]


DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96M-0274]


Summit Technology, Inc.; Premarket Approval of SVS Apex (Formerly 
the Omnimed) Excimer Laser System for 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 Summit Technology, Inc., Waltham, MA, 
for premarket approval, under the Federal Food, Drug, and Cosmetic Act 
(the act), of the SVS Apex (formerly the OmniMed) Excimer Laser System. 
After reviewing the recommendation of the Ophthalmic Devices Panel, 
FDA's Center for Devices and Radiological Health (CDRH) notified the 
applicant, by letter of October 20, 1995, of the approval of the 
application.

DATES: Petitions for administrative review by September 16, 1996.
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: Debra Y. Lewis, Center for Devices and 
Radiological Health (HFZ-460), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-827-3623.

SUPPLEMENTARY INFORMATION: On October 12, 1993, Summit Technology, 
Inc., Waltham, MA 02154, submitted to CDRH an application for premarket 
approval of the SVS Apex (formerly the OmniMed) Excimer Laser System. 
The excimer laser in the Systems delivers pulses at 193 nm wavelength. 
The excimer laser is indicated for a 6.0 mm ablation zone 
photorefractive keratectomy (PRK) in subjects with 1.5 to 7.0 diopters 
of myopia and astigmatism  1.5 diopters. On October 20, 
1995, 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 October 20, 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 September 16, 1996, 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: August 1, 1996.
D.B. Burlington,
Director, Center for Devices and Radiological Health.
[FR Doc. 96-20855 Filed 8-14-96; 8:45 am]
BILLING CODE 4160-01-F