[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] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES [Docket No. 97M-0123] Richard Wolf Medical Instruments Corp.; Premarket Approval of the Hulka ClipTubal Occlusion Device and Applicator System AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- 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