[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<Register> 
AV<SUP>TM</SUP> AICD<SUP>TM</SUP> Model 1810/Model 1815 Automatic 
Implantable Cardioverter Defibrillator (AICD<SUP>TM</SUP> ) 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<Register> AV<SUP>TM</SUP> AICD<SUP>TM</SUP> 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<Register> AV<SUP>TM</SUP> AICD<SUP>TM</SUP> Model 1810/Model 
1815 Automatic Implantable Cardioverter Defibrillator 
(AICD<SUP>TM</SUP>) 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 
<ls-thn-eq> 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<Register> AV<SUP>TM</SUP> 
AICD<SUP>TM</SUP> 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