[Federal Register Volume 59, Number 75 (Tuesday, April 19, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-9348]


[[Page Unknown]]

[Federal Register: April 19, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94M-0064]

 

Cardiac Pacemakers, Inc.; Premarket Approval of the 0060 Series 
ENDOTAK Lead 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 by Cardiac Pacemakers, Inc., St. Paul, MN, 
for premarket approval, under section 515 of the Federal Food, Drug, 
and Cosmetic Act (the act), of the 0060 Series ENDOTAK Lead 
System (the ENDOTAK Lead System). After reviewing the 
recommendation of the Circulatory System Devices Panel, FDA's Center 
for Devices and Radiological Health (CDRH) notified the applicant, by 
letter of August 26, 1993, of the approval of the application.

DATES: Petitions for administrative review by May 19, 1994.

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, rm. 
1-23, 12420 Parklawn Dr., Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Doris J. Terry, Center for Devices and 
Radiological Health (HFZ-450), Food and Drug Administration, 1390 
Piccard Dr., Rockville, MD 20850, 301-594-1523.

SUPPLEMENTARY INFORMATION: On December 19, 1991, Cardiac Pacemakers, 
Inc. (CPI), St. Paul, MN 55112, submitted to CDRH an application for 
premarket approval of the ENDOTAK Lead System. The 
ENDOTAK Lead System consists of the following: The 
ENDOTAK C Lead Models 0060, 0062, 0064; Lead Stylet Models 
6824 and 6825; ENDOTAK SQ Patch Lead Model 0063; commercially 
available AICDTM Y Connector Model 6836; and Model 0056 Bipolar 
Positive Fixation Lead and Adapter. The ENDOTAK Lead System 
is used with commercially available AICDTM Models 1550, 1555, and 
1600. The ENDOTAK Lead System is a transvenous defibrillation 
lead system and is intended for the treatment of ventricular 
tachyarrhythmias in patients who are at high risk of sudden cardiac 
death. Such patients are defined as those who have experienced one or 
more of the following: (1) Survived at least one episode of cardiac 
arrest presumably due to hemodynamically unstable ventricular 
tachyarrhythmias unassociated with acute myocardial infarction; or (2) 
recurrent ventricular tachyarrhythmias in the absence of such previous 
arrest and are inducible into sustained hypotensive ventricular 
tachycardia or ventricular fibrillation despite conventional 
antiarrhythmic drug therapy.
    A major consideration in choosing the ENDOTAK Lead System 
is that it does not require a thoracotomy. The physician should weigh 
its advantages against the patient's ability to withstand additional 
electrophysiological testing (arrhythmia induction and conversion 
testing), and a possible thoracotomy, should the lead system prove 
ineffective.
    Various factors, such as cardiomegaly or drug therapy, may 
necessitate repositioning of the defibrillating leads or substitution 
of one lead system for another in order to facilitate arrhythmia 
conversion. In some cases, reliable arrhythmia conversion may not be 
obtained with any leads at the available AICDTM energy levels.
    Bipolar pacemakers may be used with the ENDOTAK Lead 
System and AICDTM pulse generator as long as the pacemaker and 
AICDTM pulse generator do not interact causing AICDTM pulse 
generator nondetection or false detection.
    The ENDOTAK SQ Patch Lead is intended for chronic 
subcutaneous or submuscular implantation in conjunction with an 
ENDOTAK C Lead. The ENDOTAK SQ Patch Lead is not 
intended for epicardial or pericardial placement.
    On April 14, 1993, the Circulatory System Devices Panel of the 
Medical Devices Advisory Committee, an FDA advisory committee, reviewed 
and recommended approval of the application. On August 26, 1993, CDRH 
approved the application by a letter to the applicant from the Deputy 
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 (21 
U.S.C. 360e(g)), for administrative review of CDRH's decision to 
approve this application. A petitioner may request either a formal 
hearing under part 12 (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 
Sec. 10.33(b) (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 
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 May 19, 1994, 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 Center for Devices and Radiological Health (21 
CFR 5.53).

    Dated: April 5, 1994.
 Joseph A. Levitt,
 Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 94-9348 Filed 4-18-94; 8:45 am]
BILLING CODE 4160-01-F