[Federal Register Volume 63, Number 17 (Tuesday, January 27, 1998)]
[Notices]
[Page 3905]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-1943]
[[Page 3905]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98M-0038]
Guidant Corp.; Premarket Approval of VENTAK
AVTM AICDTM Model 1810/Model 1815 Automatic
Implantable Cardioverter Defibrillator (AICDTM ) with the
Model 2833 Software Application
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 Guidant Corp., St. Paul, MN, for
premarket approval, under the Federal Food, Drug, and Cosmetic Act (the
act), of the VENTAK AVTM AICDTM System.
FDA's Center for Devices and Radiological Health (CDRH) notified the
applicant, by letter of July 18, 1997, of the approval of the
application.
DATES: Petitions for administrative review by February 26, 1998.
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: Carole C. Carey, Center for Devices
and Radiological Health (HFZ-450), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-443-8609.
SUPPLEMENTARY INFORMATION: On August 20, 1996, Guidant Corp., St. Paul,
MN 55112-5798, submitted to CDRH an application for premarket approval
of VENTAK AVTM AICDTM Model 1810/Model
1815 Automatic Implantable Cardioverter Defibrillator
(AICDTM) with the Model 2833 Software Application which
consists of the following: Model 1810/Model 1815 pulse generator and
Model 2833 Software Application to be used with commercially available
Cardiac Pacemakers, Inc., Programmer/Recorder/Monitor (PRM). The device
is a multiprogrammable automatic, implantable dual-chamber pacemaker
and cardioverter defibrillator, and is indicated for use in patients
who are at high risk of sudden cardiac death due to ventricular
arrhythmias and who have experienced one of the following situations:
(1) Survival of at least one episode of cardiac arrest (manifested by
the loss of consciousness) due to a ventricular tachyarrhythmia; (2)
recurrent, poorly tolerated sustained ventricular tachycardia (VT); (3)
prior myocardial infarction, left ventricular ejection fraction of
35 percent, and a documented episode of nonsustained VT,
with an inducible ventricular tachyarrhythmia. Patients suppressible
with IV procainamide or an equivalent antiarrhythmic have not been
studied. NOTE: The clinical outcome of hemodynamically stable,
sustained-VT patients is not fully known. Safety and effectiveness
studies have not been conducted. The VENTAK AVTM
AICDTM pulse generator is not intended for use solely as a
primary bradycardia support device.
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 July 18, 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 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 February 26, 1998, 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: January 5, 1998.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 98-1943 Filed 1-26-98; 8:45 am]
BILLING CODE 4160-01-F
