[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 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 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 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]
BILLING CODE 4160-01-F
