Federal Register / Vol. 63, No. 17 /Tuesday, January 27, 1998 / Notices 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.

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

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Anesthetic and Life Support Drugs

Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee

of the Food and Drug Administration

(FDA). At least one portion of the

meeting will be closed to the public.

Name of Committee: Anesthetic and

Life Support Drugs Advisory

Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on FDA

regulatory issues.

Date and Time: The meeting will be

held on February 5, 1998, 8 a.m. to 5:30

p.m.

Location: Holiday Inn, Versailles

Ballrooms I and II, 8120 Wisconsin

Ave., Bethesda, MD.

Contact Person: Karen M. TempletonSomers, Center for Drug Evaluation and

Research (HFD–21), Food and Drug