[Federal Register Volume 62, Number 223 (Wednesday, November 19, 1997)]
[Notices]
[Pages 61824-61825]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-30333]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97M-0460]


Ventritex, Inc.; Premarket Approval of the TVL<Register> 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 submitted by Ventritex, Inc., Sunnyvale, 
CA, for premarket approval, under the Federal Food, Drug, and Cosmetic 
Act (the act), of the TVL<Register> Lead System. FDA's Center for 
Devices and Radiological Health (CDRH) notified the applicant, by 
letter of May 10, 1996, of the approval of the application.

DATES: Petitions for administrative review by December 19, 1997.

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 June 30, 1995, Ventritex, Inc., 
Sunnyvale, CA 94086-6527, submitted to CDRH an application for 
premarket approval of the TVL<Register> Lead System. The TVL<Register> 
Lead System is indicated for use with commercially available pulse 
generators with which it has been tested. The TVL<Register> Lead System 
is a transvenous defibrillation lead system and is indicated for use in 
patients with a history of hemodynamically compromising ventricular 
tachyarrhythmias. These patients may have experienced a cardiac arrest 
not associated with an acute myocardial infarction or have ventricular 
tacharrhythmias. In addition, the TVL<Register> Lead System can be used 
in patients whose primary therapy for hemodynamically significant, 
sustained ventricular tachycardia is antitachycardia pacing; the 
defibrillation capabilities of the connected pulse generator provide 
therapy backup in the event that the arrhythmia accelerates.
    In accordance with the provisions of section 515(c)(2) of the 
Federal Food, Drug, and Cosmetic Act (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 Advisory 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 May 10, 1996, 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 December 19, 1997, 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).


[[Page 61825]]


    Dated: October 16, 1997.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 97-30333 Filed 11-18-97; 8:45 am]
BILLING CODE 4160-01-F