[Federal Register Volume 62, Number 63 (Wednesday, April 2, 1997)]
[Notices]
[Pages 15713-15714]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-8274]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 97M-0123]


Richard Wolf Medical Instruments Corp.; Premarket Approval of the 
Hulka Clip<Register> Tubal Occlusion Device and Applicator System

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 Richard Wolf Medical Instruments Corp., 
Vernon Hills, IL, for premarket approval, under the Federal Food, Drug, 
and Cosmetic Act (the act), of the Hulka Clip<Register> Tubal Occlusion 
Device and Applicator System. After reviewing the recommendation of the 
Obstetrics and Gynecology Devices Panel, FDA's Center for Devices and 
Radiological Health (CDRH) notified the applicant, by letter of 
September 5, 1996, of the approval of the application.


[[Page 15714]]


DATES: Petitions for administrative review by May 2, 1997.

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:  Colin M. Pollard, Center for Devices 
and Radiological Health (HFZ-470), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-1180.

SUPPLEMENTARY INFORMATION: On December 30, 1987, Richard Wolf Medical 
Instruments Corp., Vernon Hills, IL 60061, submitted to CDRH an 
application for premarket approval of the Hulka Clip<Register> Tubal 
Occlusion Device and Applicator System. The device is a contraceptive 
tubal occlusion device and is indicated for female sterilization 
(permanent contraception) by occluding the fallopian tubes.
     On May 25, 1988, the Obstetrics and Gynecology Devices Panel of 
the Medical Devices Advisory Committee, an FDA advisory committee, 
reviewed and recommended approval of the application subject to the 
submission of the data from the long-term animal carcinogenic studies 
demonstrating the safety of the device materials. On September 5, 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 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 May 2, 1997 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: March 7, 1997.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 97-8274 Filed 4-1-97; 8:45 am]
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