[Federal Register Volume 61, Number 133 (Wednesday, July 10, 1996)] [Notices] [Page 36387] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 96-17473] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES [Docket No. 96M-0202] Intermedics, Inc.; Premarket Approval of Res-QTM ACD (Arrhythmia Control Device) Epicardial Patch and Non-thoracotomy Lead (NTL) Systems AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing its approval of the application by Intermedics, Inc., Angleton, TX, for premarket approval, under the Federal Food, Drug, and Cosmetic Act (the act), of Res-QTM ACD (Arrhythmia Control Device) Epicardial Patch and NTL Systems. After reviewing the recommendation of the Circulatory System Devices Panel, FDA's Center for Devices and Radiological Health (CDRH) notified the applicant, by letter of November 28, 1995, of the approval of the application. DATES: Petitions for administrative review by August 9, 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: Carole C. Carey, Center for Devices and Radiological Health (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-8609. SUPPLEMENTARY INFORMATION: On March 17, 1994, Intermedics, Inc., Angleton, TX 77515, submitted to CDRH an application for premarket approval of Res-QTM ACD Epicardial Patch and NTL Systems which consists of the following: Model 101-01 and 101-01R Res-QTM implantable arrhythmia control device; model 531-30 Rx2OOO GRAPHICS program module to be used with Intermedics commercially available model 522-06 Rx2OOO GRAPHICS programmer; models 497-05, 497-06, and 497-09 right ventricular (RV) defibrillation/pacing leads; model 497-15 subcutaneous patch lead; model 49716 superior vena cava (SVC) leads; models 497-01, 497-02, 497-11, and 497-12 epicardial patch leads; models A67 and L67 commercially available CPIepicardial patch leads; model 370-01 adapter; model 370-21 Y-adapter; model 370-04 Test Box; models 370-03 and 370-23 Patient Cables; model 370-05 Test Load; model 370-02 Accessory Kit; model 370-10 Lead Caps; and models 370-11, 370-12, 370-13, 370-14, 370-15, 370-16, 370-48, and 370-49 Stylets. The device is an automatic, implantable cardioverter- defibrillator (ICD) system and is indicated for use in patients who are at high risk of sudden death due to ventricular arrhythmias and have experienced one of the following situations: (1) Survival of at least one episode of cardiac arrest (manifested by a loss of consciousness) due to a ventricular tachyrhythmia; or (2) recurrent, poorly tolerated sustained ventricular tachycardia (VT). Note: The clinical outcome for hemodynamically stable, sustained-VT patients is not fully known. Safety and effectiveness studies have not been conducted. On August 21, 1995, the Circulatory System Devices Panel of the Medical Devices Advisory Committee, an FDA advisory committee, review and recommended approval of the application. On November 28, 1995, 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 (21 U.S.C. 360e(g)), 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 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 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 August 9, 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: April 9, 1996. Joseph A. Levitt, Deputy Director for Regulations Policy, Center for Devices and Radiological Health. [FR Doc. 96-17473 Filed 7-9-96; 8:45 am] BILLING CODE 4160-01-F