[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: 94-9350]
[[Page Unknown]]
[Federal Register: April 19, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94M-0063]
Medtronic, Inc.; Premarket Approval of the Medtronic
Transvene 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 Medtronic, Inc., Minneapolis, MN, for
premarket approval, under section 515 of the Federal Food, Drug, and
Cosmetic Act (the act), of the Medtronic Transvene
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 December 9, 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 April 1, 1992, Medtronic, Inc.,
Minneapolis, MN, 55432, submitted to CDRH an application for premarket
approval of the Medtronic Transvene Lead System.
The device is a transvenous defibrillation lead system and is intended
for single long-term use, and each lead is designed to be used only
with a compatible Medtronic, Inc., implantable tachyarrhythmia control
device along with at least one other Medtronic, Inc., defibrillator
lead. The lead system has application where implantable tachyarrhythmia
cardioversion or defibrillation systems are indicated. Current medical
research indicates that such patients should: (1) Have survived at
least one episode of a cardiac arrest, presumably due to a ventricular
tachyarrhythmia as evidenced by resuscitation using a transthoracic
defibrillator. The ventricular tachyarrhythmia should not have been
caused by an acute myocardial infarction; or (2) in the absence of a
prior cardiac arrest, have poorly tolerated sustained ventricular
tachycardia and/or ventricular fibrillation, which occurs
spontaneously, or can be induced, despite the best antiarrhythmic drug
therapy.
The natural history of patients with hemodynamically stable
sustained ventricular tachycardia is not well defined. While this
patient population was included in the Transvene lead
clinical study, no conclusions were drawn from the data obtained on
this specific patient group.
Prior to a Transvene implant, it is strongly recommended
that patients undergo a complete cardiac evaluation, which should
include extensive electrophysiologic testing. Also, extensive
electrophysiologic evaluation and testing of the safety and efficacy of
the proposed pacing, cardioversion, or defibrillation therapies are
recommended during and after the implantation of the
Transvene system.
On August 2, 1993, the Circulatory System Devices Panel of the
Medical Devices Advisory Committee, an FDA advisory committee, reviewed
and recommended approval of the application. On December 9, 1993, CDRH
approved the application by a letter to the applicant from the Acting
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. 94-9350 Filed 4-18-94; 8:45 am]
BILLING CODE 4160-01-F
