[Federal Register Volume 61, Number 231 (Friday, November 29, 1996)]
[Notices]
[Page 60713]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-30508]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96M-0451]
Cardiac Pacemakers, Inc.; Premarket Approval of VIGOR
DR Pacemaker System/VIGOR SR Pacemaker 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 Cardiac Pacemakers, Inc., St. Paul, MN,
for premarket approval, under the Federal Food, Drug, and Cosmetic Act
(the act), of the VIGOR DR Pacemaker System/VIGOR
SR Pacemaker System. After reviewing the recommendation of the
Circulatory System Devices Panel, FDA's Center for Devices and
Radiological Health (CDRH) notified the applicant, by letter on June
21, 1995, of the approval of the application.
DATES: Petitions for administrative review by December 30, 1996.
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 September 30, 1994, Cardiac Pacemakers,
Inc., St. Paul, MN 55112, submitted to CDRH an application for
premarket approval of the following: VIGOR DR (dual chamber)
Model 1230/1235 Pulse Generators, VIGOR SR (single chamber)
Model 1130/1135 Pulse Generators, and the Model 2075 Software Module to
be used with commercially available CPI Model 2035 Handheld
Programmer and Model 6575 or 6577 Telemetry Wand; Model 6942
Bidirectional Torque Wrench; Model 6562 Horseshoe Magnet; Model 6580
Electrogram Cable; Model 6589 Printer Paper; and commercially available
pacemaker leads and accessories that are compatible with the pulse
generators. The devices are generally indicated for long-term cardiac
pacing. Generally accepted indications for long-term pacing include,
but are not limited to, sick sinus syndrome; chronic sinus arrhythmias;
including sinus bradycardia; sinus arrest; and sinoatrial (SA) block;
second- and third-degree atrioventricular (AV) block; bradycardia-
tachycardia syndrome; and carotid sinus syndrome. Patients who
demonstrate hemodynamic improvement from AV synchrony should be
considered for one of the dual-chamber or atrial pacing modes. Dual-
chamber modes are specifically indicated for treatment of conduction
disorders that require restoration of rate and AV synchrony, including
varying degrees of AV block; low cardiac output or congestive heart
failure related to bradycardia; and certain tachyarrhythmias. The
adaptive-rate pacing modes of the VIGOR DR and
VIGOR SR pulse generators are indicated for patients
exhibiting chronotropic incompetence and who would benefit by increased
pacing rates concurrent with physical activity.
On May 9, 1995, the Circulatory System Devices Panel of the Medical
Devices Advisory Committee, an FDA advisory committee, reviewed and
recommended approval of the application. On June 21, 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 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 30, 1996, 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: November 7, 1996.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 96-30508 Filed 11-27-96; 8:45 am]
BILLING CODE 4160-01-F
