[Federal Register Volume 59, Number 75 (Tuesday, April 19, 1994)] [Unknown Section] [Page 0] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 94-9348] [[Page Unknown]] [Federal Register: April 19, 1994] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES [Docket No. 94M-0064] Cardiac Pacemakers, Inc.; Premarket Approval of the 0060 Series ENDOTAKLead System AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing its approval of the application by Cardiac Pacemakers, Inc., St. Paul, MN, for premarket approval, under section 515 of the Federal Food, Drug, and Cosmetic Act (the act), of the 0060 Series ENDOTAK Lead System (the ENDOTAK Lead System). 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 August 26, 1993, of the approval of the application. DATES: Petitions for administrative review by May 19, 1994. 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, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857. FOR FURTHER INFORMATION CONTACT: Doris J. Terry, Center for Devices and Radiological Health (HFZ-450), Food and Drug Administration, 1390 Piccard Dr., Rockville, MD 20850, 301-594-1523. SUPPLEMENTARY INFORMATION: On December 19, 1991, Cardiac Pacemakers, Inc. (CPI), St. Paul, MN 55112, submitted to CDRH an application for premarket approval of the ENDOTAK Lead System. The ENDOTAK Lead System consists of the following: The ENDOTAK C Lead Models 0060, 0062, 0064; Lead Stylet Models 6824 and 6825; ENDOTAK SQ Patch Lead Model 0063; commercially available AICDTM Y Connector Model 6836; and Model 0056 Bipolar Positive Fixation Lead and Adapter. The ENDOTAK Lead System is used with commercially available AICDTM Models 1550, 1555, and 1600. The ENDOTAK Lead System is a transvenous defibrillation lead system and is intended for the treatment of ventricular tachyarrhythmias in patients who are at high risk of sudden cardiac death. Such patients are defined as those who have experienced one or more of the following: (1) Survived at least one episode of cardiac arrest presumably due to hemodynamically unstable ventricular tachyarrhythmias unassociated with acute myocardial infarction; or (2) recurrent ventricular tachyarrhythmias in the absence of such previous arrest and are inducible into sustained hypotensive ventricular tachycardia or ventricular fibrillation despite conventional antiarrhythmic drug therapy. A major consideration in choosing the ENDOTAK Lead System is that it does not require a thoracotomy. The physician should weigh its advantages against the patient's ability to withstand additional electrophysiological testing (arrhythmia induction and conversion testing), and a possible thoracotomy, should the lead system prove ineffective. Various factors, such as cardiomegaly or drug therapy, may necessitate repositioning of the defibrillating leads or substitution of one lead system for another in order to facilitate arrhythmia conversion. In some cases, reliable arrhythmia conversion may not be obtained with any leads at the available AICDTM energy levels. Bipolar pacemakers may be used with the ENDOTAK Lead System and AICDTM pulse generator as long as the pacemaker and AICDTM pulse generator do not interact causing AICDTM pulse generator nondetection or false detection. The ENDOTAK SQ Patch Lead is intended for chronic subcutaneous or submuscular implantation in conjunction with an ENDOTAK C Lead. The ENDOTAK SQ Patch Lead is not intended for epicardial or pericardial placement. On April 14, 1993, the Circulatory System Devices Panel of the Medical Devices Advisory Committee, an FDA advisory committee, reviewed and recommended approval of the application. On August 26, 1993, CDRH approved the application by a letter to the applicant from the Deputy 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 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 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 19, 1994, 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 Center for Devices and Radiological Health (21 CFR 5.53). Dated: April 5, 1994. Joseph A. Levitt, Deputy Director for Regulations Policy, Center for Devices and Radiological Health. [FR Doc. 94-9348 Filed 4-18-94; 8:45 am] BILLING CODE 4160-01-F