[Federal Register Volume 62, Number 96 (Monday, May 19, 1997)]
[Notices]
[Pages 27260-27261]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-13023]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97M-0185]
ELA Medical, Inc.; Premarket Approval of Chorus RM Model 7034
DDDR Pacemaker System and Opus RM Model 4534 SSIR Pacemaker System
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 submitted by ELA Medical, Inc., Plymouth,
MN, for premarket approval, under the Federal Food, Drug, and Cosmetic
Act (the act), of Chorus RM Model 7034 DDDR Pacemaker System and Opus
RM Model 4534 SSIR Pacemaker System. FDA's Center for Devices and
Radiological Health (CDRH) notified the applicant, by letter of March
10, 1997, of the approval of the application.
DATES: Petitions for administrative review by June 18, 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: Marian Kroen, Center for Devices and
Radiological Health (HFZ-450), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-443-8517.
SUPPLEMENTARY INFORMATION: On January 18, 1996, ELA Medical, Inc.,
Plymouth, MN 55441, submitted to CDRH an application for premarket
approval of Chorus RM Model 7034 DDDR Pacemaker System and Opus RM
Model 4534 SSIR Pacemaker System which includes an IBM compatible
microcomputer which has been configured and furnished by ELA Medical,
Inc., with CSO 2.46 programming software and is connected to a CPR1
programming lead. These devices are implantable cardiac pacemakers and
are indicated for: (1) Rate adaptive pacing in patients who may benefit
from increased pacing rates concurrent with increases in minute
ventilation; (2) The generally accepted patient conditions warranting
chronic cardiac pacing which include:
Symptomatic paroxysmal or permanent second or third-degree
AV block;
Symptomatic bilateral bundle branch block;
Symptomatic paroxysmal or transient sinus node
dysfunctions with or without associated AV conduction disorders;
Bradycardia-tachycardia syndrome to prevent symptomatic
bradycardia or some forms of symptomatic tachyarrhythmias; and
Vaso-vagal syndromes or hypersensitive carotid sinus
syndromes.
The Chorus RM is also indicated for dual-chamber and atrial
tracking modes in patients who may benefit from maintenance of AV
synchrony. Dual-chamber modes are specifically indicated for treatment
of conduction disorders that require restoration of both rate and AV
synchrony which include:
Various degrees of AV block to maintain the atrial
contribution to cardiac output; and
VVI intolerance (e.g., pacemaker syndrome) in the presence
of persistent sinus rhythm.
In accordance with the provisions of section 515(c)(2) of the act
as amended by the Safe Medical Devices Act of 1990, this 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
[[Page 27261]]
duplicates information previously reviewed by this panel.
On March 10, 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 (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 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 June 18, 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: April 22, 1997.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 97-13023 Filed 5-16-97; 8:45 am]
BILLING CODE 4160-01-F
