[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