[Federal Register Volume 59, Number 87 (Friday, May 6, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-10919]
[[Page Unknown]]
[Federal Register: May 6, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICE
[Docket No. 94M-0129]
Pace Medical, Inc.; Premarket Approval of the Model 4553 MICRO-
PACETM Dual-Chamber, DDD, Temporary Cardiac Pacemaker
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 Pace Medical, Inc., Waltham, MA, for
premarket approval, under section 515 of the Federal Food, Drug, and
Cosmetic Act (the act), of the Model 4553 MICRO-PACETM Dual-
Chamber, DDD, Temporary Cardiac Pacemaker (Model 4553 MICRO-
PACETM). FDA's Center for Devices and Radiological Health (CDRH)
notified the applicant, by letter of March 10, 1994, of the approval of
the application.
DATES: Petitions for administrative review by June 6, 1994.
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: James Cheng, Center for Devices and
Radiological Health (HFZ-450), Food and Drug Administration, 1390
Piccard Dr., Rockville, MD 20850, 301-594-2720.
SUPPLEMENTARY INFORMATION: On June 30, 1992, Pace Medical, Inc.,
Waltham, MA 02154, submitted to CDRH an application for premarket
approval of the Model 4553 MICRO-PACETM. The device is a temporary
external pulse generator and is indicated for use in any clinical
situation in which the use of a temporary pacemaker on a patient
provides therapeutic or diagnostic value or serves a prophylactic
purpose. Indications for the use of temporary cardiac pacemakers
include, but are not limited to, the following: Intermittent or
complete heart block associated with asystole or bradycardia,
symptomatic sinus bradycardia, surgically induced heart block, and
heart block accompanying an acute myocardial infarction.
Additionally, temporary cardiac pacing has been used to overdrive,
and thereby terminate, atrial arrhythmias, including atrial flutter. It
has been used in preparation for permanent pacemaker implantation to
ascertain the thresholds for sensing and pacing on the acute lead
system. Although the intended uses of the Model 4553 MICRO-PACETM
are primarily therapeutic and prophylactic, the ability to extensively
program both the amplitude of the constant voltage output and the pulse
width in the Model 4553 MICRO-PACETM does make it, when necessary,
a satisfactory alternative to a properly functioning pacing system
analyzer for the thresholds for sensing and stimulation.
In accordance with the provisions of section 515(f)(2) of the act
(21 U.S.C. 360e(f)(2)) as amended by the Safe Medical Devices Act of
1990 (Pub. L. 101-629), this premarket approval application (PMA) was
not referred to the Circulatory System Devices Panel, an FDA advisory
panel, for review and recommendation because the information in the PMA
substantially duplicates information previously reviewed by this panel.
On March 10, 1994, CDRH approved the application by a letter to the
applicant from the Acting 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 (21
U.S.C. 360e(g)), 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 June 6, 1994, 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 Center for Devices and Radiological Health (21
CFR 5.53).
Dated: April 20, 1994.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 94-10919 Filed 5-5-94; 8:45 am]
BILLING CODE 4160-01-F
