[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 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 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 Lead System. The TVL
Lead System is indicated for use with commercially available pulse
generators with which it has been tested. The TVL 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 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
