[Federal Register Volume 62, Number 63 (Wednesday, April 2, 1997)]
[Notices]
[Pages 15714-15715]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-8273]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 97M-0121]
Medtronic, Inc.; Premarket Approval of the Legend Plus
Pacing System
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing its
approval of the application by Medtronic, Inc., Minneapolis, MN, for
premarket approval, under the Federal Food, Drug, and Cosmetic Act (the
act), of the Legend Plus Pacing 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 of February 7, 1997, of the approval of the application.
DATES: Petitions for administrative review by May 2, 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: Mitchell J. Shein, Center for Devices
and Radiological Health (HFZ-450), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-443-8517.
SUPPLEMENTARY INFORMATION: On July 21, 1993, Medtronic, Inc.,
Minneapolis, MN 55432, submitted to CDRH an application for premarket
approval of the Legend Plus Pacing System. The device
consists of the following components: The Legend Plus Pulse
Generator Models 8446 and 8448; the Model 9790 and 9790C Programmers
with the Model 9891 Baseline Software and the Model 9807 Software. The
device system includes implantable pulse generators and associated
programming hardware and software and is indicated for permanent
ventricular or atrial pacing applications. Their use is indicated in
the treatment of patients who may benefit from a pacing rate that
changes in response to activity.
Ventricular indications include: (1) Chronic atrial flutter or
fibrillation with slow ventricular response; (2) sinus node dysfunction
or sick sinus syndrome (e.g., sinus bradycardia, sinus arrest and/or
exit block, bradycardia-tachycardia syndrome, chronotropic
insufficiency, etc.,); and (3) AV block.
Atrial indications include: Sinus node dysfunction or sick sinus
syndrome (e.g., sinus bradycardia, sinus arrest and/or exit block,
bradycardia-tachycardia syndrome, etc.,) with intact AV conduction.
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 February 7, 1997, 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
[[Page 15715]]
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 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 2, 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).
Dated: March 4, 1997.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 97-8273 Filed 4-1-97; 8:45 am]
BILLING CODE 4160-01-F
