[Federal Register Volume 62, Number 243 (Thursday, December 18, 1997)]
[Notices]
[Pages 66374-66375]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-32968]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97M-0500]


Telectronics Pacing Systems, Inc.; Premarket Approval of 
Telectronics Guardian<SUP>TM</SUP> ATP II Model 4211 Implantable 
Cardioverter Defibrillator 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 Telectronics Pacing Systems, Inc., 
Englewood, CO, for premarket approval, under the Federal Food, Drug, 
and Cosmetic Act (the act), of the Guardian<SUP>TM</SUP> ATP II Model 
4211 Implantable Cardioverter Defibrillator System. FDA's Center for 
Devices and Radiological Health (CDRH) notified the applicant, by 
letter of July 3, 1997, of the approval of the application.

DATES: Petitions for administrative review by January 20, 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: Doris J. Terry, Center for Devices and 
Radiological Health (HFZ-450), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-443-8609.

SUPPLEMENTARY INFORMATION: On July 8, 1994, Telectronics Pacing 
Systems, Inc., Englewood, CO 80112, submitted to CDRH an application 
for premarket approval of the Guardian<SUP>TM</SUP> ATP II Model 4211 
Implantable Cardioverter Defibrillator System. The 
Guardian<SUP>TM</SUP> ATP II Model 4211 Implantable Cardioverter 
Defibrillator System is indicated for use in patients who are at high 
risk of sudden death due to ventricular fibrillation and/or ventricular 
tachyrhythmias and who have experienced one of the following 
situations:
    <bullet>  survival of at least one episode of cardiac arrest 
(manifested by a loss of consciousness) due to a ventricular 
tachyrhythmia
    <bullet>  recurrent, poorly tolerated sustained ventricular 
tachycardia (VT).
Note: The clinical outcome for hemodynamically stable, sustained-VT 
patients is not fully known. Safety and effectiveness studies have not 
been conducted.
    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 3, 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 January 20, 1998, file 
with the Dockets Management Branch (address above) two copies of each 
petition and supporting data and information,

[[Page 66375]]

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: October 31, 1997.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 97-32968 Filed 12-17-97; 8:45 am]
BILLING CODE 4160-01-F