[Federal Register Volume 63, Number 17 (Tuesday, January 27, 1998)] [Notices] [Page 3905] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 98-1943] [[Page 3905]] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 98M-0038] Guidant Corp.; Premarket Approval of VENTAKAVTM AICDTM Model 1810/Model 1815 Automatic Implantable Cardioverter Defibrillator (AICDTM ) with the Model 2833 Software Application AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing its approval of the application by Guidant Corp., St. Paul, MN, for premarket approval, under the Federal Food, Drug, and Cosmetic Act (the act), of the VENTAK AVTM AICDTM System. FDA's Center for Devices and Radiological Health (CDRH) notified the applicant, by letter of July 18, 1997, of the approval of the application. DATES: Petitions for administrative review by February 26, 1998. 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 August 20, 1996, Guidant Corp., St. Paul, MN 55112-5798, submitted to CDRH an application for premarket approval of VENTAK AVTM AICDTM Model 1810/Model 1815 Automatic Implantable Cardioverter Defibrillator (AICDTM) with the Model 2833 Software Application which consists of the following: Model 1810/Model 1815 pulse generator and Model 2833 Software Application to be used with commercially available Cardiac Pacemakers, Inc., Programmer/Recorder/Monitor (PRM). The device is a multiprogrammable automatic, implantable dual-chamber pacemaker and cardioverter defibrillator, and is indicated for use in patients who are at high risk of sudden cardiac death due to ventricular arrhythmias and who have experienced one of the following situations: (1) Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to a ventricular tachyarrhythmia; (2) recurrent, poorly tolerated sustained ventricular tachycardia (VT); (3) prior myocardial infarction, left ventricular ejection fraction of 35 percent, and a documented episode of nonsustained VT, with an inducible ventricular tachyarrhythmia. Patients suppressible with IV procainamide or an equivalent antiarrhythmic have not been studied. NOTE: The clinical outcome of hemodynamically stable, sustained-VT patients is not fully known. Safety and effectiveness studies have not been conducted. The VENTAK AVTM AICDTM pulse generator is not intended for use solely as a primary bradycardia support device. In accordance with the provisions of section 515(c)(2) of the act (21 U.S.C. 360e(c)(2)) as amended by the Safe Medical Devices Act of 1990, this premarket approval application (PMA) was not referred to the Circulatory System Devices Panel of the Medical Devices Advisory Committee, an FDA advisory committee, for review and recommendation because the information in the PMA substantially duplicates information previously reviewed by this panel. On July 18, 1997, 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 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 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 February 26, 1998, 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: January 5, 1998. Joseph A. Levitt, Deputy Director for Regulations Policy, Center for Devices and Radiological Health. [FR Doc. 98-1943 Filed 1-26-98; 8:45 am] BILLING CODE 4160-01-F