97-17288. Biotronik, Inc.; Premarket Approval of Dromos DR/DR-A and Dromos SR/SR-B Cardiac Pacing Systems  

  • [Federal Register Volume 62, Number 127 (Wednesday, July 2, 1997)]
    [Notices]
    [Page 35821]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 97-17288]
    
    
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    DEPARTMENT OF HEALTH AND HUMAN SERVICES
    
    Food and Drug Administration
    [Docket No. 97M-0251]
    
    
    Biotronik, Inc.; Premarket Approval of Dromos DR/DR-A and Dromos 
    SR/SR-B Cardiac Pacing Systems
    
    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 Biotronik, Inc., Lake Oswego, OR, for 
    premarket approval, under the Federal Food, Drug, and Cosmetic Act (the 
    act), of the Dromos DR/DR-A and Dromos SR/SR-B Cardiac Pacing Systems. 
    FDA's Center for Devices and Radiological Health (CDRH) notified the 
    applicant, by letter of October 11, 1996, of the approval of the 
    application.
    
    DATES: Petitions for administrative review by August 1, 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: Robert J. Mazzaferro, Center for 
    Devices and Radiological Health (HFZ-450), Food and Drug 
    Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-
    8517.
    
    SUPPLEMENTARY INFORMATION: On February 21, 1996, Biotronik, Inc., Lake 
    Oswego, OR 97035-5369, submitted to CDRH an application for premarket 
    approval of the Dromos DR/DR-A and Dromos SR/SR-B Cardiac Pacing 
    Systems. The BIOTRONIK Dromos DR and Dromos SR are rate adaptive 
    multiprogrammable pulse generators. The Dromos DR is an atrial-based 
    dual-chamber pacemaker and the Dromos SR is a single-chamber pacemaker 
    suitable for either atrial or ventricular pacing therapy. The Dromos DR 
    and Dromos SR have an accelerometer-based sensor and a rate-adaptive 
    algorithm designed to automatically adjust the pacing rate to meet the 
    patient's level of exertion. Rate adaptive pacing with the Dromos DR 
    and Dromos SR pulse generators is indicated for patients exhibiting 
    chronotropic incompetence and who would benefit from increased pacing 
    rates concurrent with physical activity. Generally accepted indications 
    for long-term cardiac pacing include, but are not limited to: Sick 
    sinus syndrome (i.e., bradycardia-tachycardia syndrome, sinus arrest, 
    sinus bradycardia), sino-atrial (SA) block, second- and third-degree AV 
    block, and carotid sinus syndrome. Patients who demonstrate hemodynamic 
    benefit through maintenance of AV synchrony should be considered for 
    one of the dual-chamber or atrial pacing modes. Dual-chamber modes are 
    specifically indicated for treatment of conduction disorders that 
    require both restoration of rate and AV synchrony such as AV nodal 
    disease, diminished cardiac output or congestive heart failure 
    associated with conduction disturbances, and tachyarrhythmias that are 
    suppressed by chronic pacing.
        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 October 11, 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 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 August 1, 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: June 10, 1997.
    Joseph A. Levitt,
    Deputy Director for Regulations Policy, Center for Devices and 
    Radiological Health.
    [FR Doc. 97-17288 Filed 7-1-97; 8:45 am]
    BILLING CODE 4160-01-F
    
    
    

Document Information

Published:
07/02/1997
Department:
Food and Drug Administration
Entry Type:
Notice
Action:
Notice.
Document Number:
97-17288
Dates:
Petitions for administrative review by August 1, 1997.
Pages:
35821-35821 (1 pages)
Docket Numbers:
Docket No. 97M-0251
PDF File:
97-17288.pdf