[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