[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