[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]
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