[Federal Register Volume 63, Number 26 (Monday, February 9, 1998)]
[Notices]
[Page 6572]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-3206]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98M-0050]


American Medical Systems Inc.; Premarket Approval of the 
UroLumeTM Endourethral Prostatic for Prostatic Obstruction 
Secondary to Benign Prostatic Hypertrophy

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 American Medical Systems Inc., 
Minnetonka, MN, for premarket approval, under the Federal Food, Drug, 
and Cosmetic Act (the act), of the UroLumeTM Endourethral 
Prostatic for Prostatic Obstruction Secondary to Benign Prostatic 
Hypertrophy (BPH). After reviewing the recommendation of the 
Gastroenterology-Urology Devices Panel, FDA's Center for Devices and 
Radiological Health (CDRH) notified the applicant, by letter of April 
11, 1997, of the approval of the application.

DATES: Petitions for administrative review by March 11, 1998.

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: James P. Seiler, Center for Devices 
and Radiological Health (HFZ-470), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-2194.

SUPPLEMENTARY INFORMATION: On May 6, 1996, American Medical Systems 
Inc., Minnetonka, MN 55343, submitted to CDRH an application for 
premarket approval of the UroLumeTM Endourethral Prostatic 
for Prostatic Obstruction Secondary to BPH. The device is intended to 
relieve prostatic obstruction secondary to BPH in men at least 60 years 
of age, or men under 60 years of age who are poor surgical candidates, 
and whose prostates are at least 2.5 centimeters in length.

    On January 16, 1997, the Gastroenterology-Urology Devices Panel of 
the Medical Devices Advisory Committee, an FDA advisory committee, 
reviewed and recommended approval of the application. On April 11, 
1997, 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 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 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 March 11, 1998, 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 17, 1997.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 98-3206 Filed 2-6-98; 8:45 am]
BILLING CODE 4160-01-F