[Federal Register Volume 60, Number 77 (Friday, April 21, 1995)]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-9950]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 95M-0072]
Cardiac Pacemakers, Inc., Premarket Approval of VENTAK
P2 AICDTM System: Model 1625 VENTAK P2 Pulse Generator,
Model 2835 Software Module, and Model 2815 VENTAK ECD
External Cardioverter Defibrillator
AGENCY: Food and Drug Administration, HHS.
SUMMARY: The Food and Drug Administration (FDA) is announcing its
approval of the application by Cardiac Pacemakers, Inc., St. Paul, MN,
for premarket approval, under the Federal Food, Drug, and Cosmetic Act
(the act), of the VENTAK P2 AICDTM System. FDA's Center
for Devices and Radiological Health (CDRH) notified the applicant, by
letter of March 10, 1995, of the approval of the application.
DATES: Petitions for administrative review by May 22, 1995.
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, rm.
1-23, 12420 Parklawn Dr., 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 30, 1993, Cardiac Pacemakers,
Inc., St. Paul, MN 55112, submitted to CDRH an application for
premarket approval of VENTAK P2 AICDTM System consists
of the following: Model 1625 VENTAK P2 pulse generator; Model
2835 Software Module to be used with commercially available Cardiac
Pacemakers, Inc., (CPI) Model 2035 Handheld Programmer and
Model 6575 or 6577 Telemetry Wand; Model 2815 VENTAK ECD
External Cardioverter Defibrillator (which includes the Model 6873 High
Voltage Cable with Model 6838 Thumbscrew, Model 6843 Bipolar Cable with
Model 6838 Thumbscrew, Model 6874 Bipolar Cable, and related
CPI commercially available accessories); commercially
available CPI ENDOTAK 60-Series Lead System and
accessories; commercially available CPI epicardial
defibrillation leads and accessories; and commercially available pace/
sense leads and accessories. The device is an automatic implantable
cardioverter defibrillator system and is indicated for the treatment of
patients with ventricular fibrillation and/or ventricular
tachyarrhythmias who are at high risk of sudden cardiac death. Such
patients are defined as having experienced the following situations:
(1) The survival of at least one episode of cardiac arrest presumably
due to hemodynamically unstable ventricular tachyarrhythmia not
associated with acute myocardial infarction, and/or (2) a poorly
tolerated, sustained ventricular tachycardia (VT) and/or ventricular
fibrillation (VF) which recurs spontaneously or can be induced despite
the best antiarrhythmic drug therapy. Note: The clinical outcome of
hemodynamically stable, sustained VT patients is not fully known. A
study of the safety and effectiveness of the VENTAK P2 system
on this selected subgroup of VT patients has 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 [[Page 19949]] 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 March 10,
1995, 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 (21 U.S.C. 360e(d)(3)) 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 part 12 (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 Sec. 10.33(b) (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 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 May 22, 1995, 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: April 6, 1995.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and
[FR Doc. 95-9950 Filed 4-20-95; 8:45 am]
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