[Federal Register Volume 61, Number 197 (Wednesday, October 9, 1996)]
[Notices]
[Page 52949]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-25877]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96M-0356]
American Medical Systems, Inc.; Premarket Approval of
UroLumeTM Endourethral Prosthesis
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
Prosthesis. After reviewing the recommendation of the Gastroenterology
and Urology Devices Panel, FDA's Center for Devices and Radiological
Health (CDRH) notified the applicant, by letter of May 6, 1996, of the
approval of the application.
DATES: Petitions for administrative review by November 8, 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: James P. Seiler, Center for Devices
and Radiological Health (HFZ-470), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-1195.
SUPPLEMENTARY INFORMATION: On June 14, 1993, American Medical Systems,
Inc., Minnetonka, MN 55343, submitted to CDRH an application for
premarket approval of the UroLumeTM Endourethral Prosthesis. The
device is intended for use in men to relieve urinary obstruction
secondary to recurrent benign bulbar urethral strictures less than 3
centimeters in length located distal to the external sphincter and
proximal to the bulbar scrotal junction. The UroLumeTM
Endourethral Prosthesis is not intended as an initial treatment for
bulbar urethral strictures nor for the treatment of strictures outside
the bulbar urethra. The UroLumeTM Endourethral Prosthesis is an
alternative treatment for the patient in whom previous treatment
methods (e.g., dilation, urethrotomy, or urethroplasty) have been
unsuccessful (i.e., treatment was not effective initially in relieving
stricture disease, or there has been recurrence of stricture formation
necessitating further treatment).
On January 20, 1995, the Gastroenterology and Urology Devices Panel
of the Medical Devices Advisory Committee, an FDA advisory committee,
reviewed and recommended approval of the application. On May 6, 1996,
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 November 8, 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: September 20, 1996.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 96-25877 Filed 10-8-96; 8:45 am]
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