[Federal Register Volume 60, Number 82 (Friday, April 28, 1995)]
[Notices]
[Page 20999]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-10429]
[[Page 20999]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95M-0057]
Medtronic CardioRhythm; Premarket Approval of Atakr Radio
Frequency Catheter Ablation 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 Medtronic CardioRhythm, San Jose, CA,
for premarket approval, under the Federal Food, Drug, and Cosmetic Act
(the act), of the Atakr Radio Frequency Catheter Ablation 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 9, 1995, of the approval of the
application.
DATES: Petitions for administrative review by May 30, 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: Mark Massi, 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 26, 1993, Medtronic CardioRhythm,
San Jose, CA 95134, submitted to CDRH an application for premarket
approval of the Atakr Radio Frequency Catheter Ablation System. The
device is a radio frequency power cardiac catheter ablation system, and
it is indicated for interruption of accessory atrioventricular (AV)
conduction pathways associated with tachycardia, for the treatment of
AV nodal re-entrant tachycardia, and for creation of complete AV block
in patients with a difficult to control ventricular response to an
atrial arrhythmia.
On December 5, 1994, the Circulatory System Devices Panel of the
Medical Devices Advisory Committee, an FDA advisory committee, reviewed
and recommended approval of the application. On February 9, 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 (insert date 30 days
after date of publication in the Federal Register), 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 3, 1995.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 95-10429 Filed 4-27-95; 8:45 am]
BILLING CODE 4160-01-F
