95-9950. Cardiac Pacemakers, Inc., Premarket Approval of VENTAKRegister P2 AICDSUPTM System: Model 1625 VENTAKRegister P2 Pulse Generator, Model 2835 Software Module, and Model 2815 VENTAKRegister ECD External Cardioverter Defibrillator  

  • [Federal Register Volume 60, Number 77 (Friday, April 21, 1995)]
    [Notices]
    [Pages 19948-19949]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 95-9950]
    
    
    
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    DEPARTMENT OF HEALTH AND HUMAN SERVICES
    Food and Drug Administration
    [Docket No. 95M-0072]
    
    
    Cardiac Pacemakers, Inc., Premarket Approval of VENTAK 
    P2 AICDTM System: Model 1625 VENTAK P2 Pulse Generator, 
    Model 2835 Software Module, and Model 2815 VENTAK ECD 
    External Cardioverter Defibrillator
    
    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 Cardiac Pacemakers, Inc., St. Paul, MN, 
    for premarket approval, under the Federal Food, Drug, and Cosmetic Act 
    (the act), of the VENTAK P2 AICDTM System. FDA's Center 
    for Devices and Radiological Health (CDRH) notified the applicant, by 
    letter of March 10, 1995, of the approval of the application.
    
    DATES: Petitions for administrative review by May 22, 1995.
    
    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: 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 30, 1993, Cardiac Pacemakers, 
    Inc., St. Paul, MN 55112, submitted to CDRH an application for 
    premarket approval of VENTAK P2 AICDTM System consists 
    of the following: Model 1625 VENTAK P2 pulse generator; Model 
    2835 Software Module to be used with commercially available Cardiac 
    Pacemakers, Inc., (CPI) Model 2035 Handheld Programmer and 
    Model 6575 or 6577 Telemetry Wand; Model 2815 VENTAK ECD 
    External Cardioverter Defibrillator (which includes the Model 6873 High 
    Voltage Cable with Model 6838 Thumbscrew, Model 6843 Bipolar Cable with 
    Model 6838 Thumbscrew, Model 6874 Bipolar Cable, and related 
    CPI commercially available accessories); commercially 
    available CPI ENDOTAK 60-Series Lead System and 
    accessories; commercially available CPI epicardial 
    defibrillation leads and accessories; and commercially available pace/
    sense leads and accessories. The device is an automatic implantable 
    cardioverter defibrillator system and is indicated for the treatment of 
    patients with ventricular fibrillation and/or ventricular 
    tachyarrhythmias who are at high risk of sudden cardiac death. Such 
    patients are defined as having experienced the following situations: 
    (1) The survival of at least one episode of cardiac arrest presumably 
    due to hemodynamically unstable ventricular tachyarrhythmia not 
    associated with acute myocardial infarction, and/or (2) a poorly 
    tolerated, sustained ventricular tachycardia (VT) and/or ventricular 
    fibrillation (VF) which recurs spontaneously or can be induced despite 
    the best antiarrhythmic drug therapy. Note: The clinical outcome of 
    hemodynamically stable, sustained VT patients is not fully known. A 
    study of the safety and effectiveness of the VENTAK P2 system 
    on this selected subgroup of VT patients has not been conducted.
         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 [[Page 19949]] 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 March 10, 
    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, 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 22, 1995, 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 6, 1995.
    Joseph A. Levitt,
    Deputy Director for Regulations Policy, Center for Devices and 
    Radiological Health.
    [FR Doc. 95-9950 Filed 4-20-95; 8:45 am]
    BILLING CODE 4160-01-F
    
    

Document Information

Published:
04/21/1995
Department:
Food and Drug Administration
Entry Type:
Notice
Action:
Notice.
Document Number:
95-9950
Dates:
Petitions for administrative review by May 22, 1995.
Pages:
19948-19949 (2 pages)
Docket Numbers:
Docket No. 95M-0072
PDF File:
95-9950.pdf