[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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