[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