[Federal Register Volume 60, Number 109 (Wednesday, June 7, 1995)]
[Notices]
[Pages 30089-30090]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-13827]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95M-0121]
EP Technologies, Inc.; Premarket Approval of EPT-1000 Cardiac
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 EP Technologies, Inc., Sunnyvale, CA,
for premarket approval, under the Federal Food, Drug, and Cosmetic Act
(the act), of the EPT-1000 Cardiac 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 October 28, 1994, of the approval of the application.
DATES: Petitions for administrative review by July 7, 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 September 28, 1992, EP Technologies,
Inc., Sunnyvale, CA 94086, submitted to CDRH an application for
premarket approval of the EPT-1000 Cardiac Ablation System. The device
is a radio frequency-powered cardiac catheter ablation system and is
indicated for interruption of accessory atrioventricular (AV)
conduction pathways associated with tachycardia, treatment of AV nodal
re-entrant tachycardia, and for creation of complete AV block in
patients with a rapid ventricular response to an atrial arrhythmia-
typically chronic, drug refractory atrial fibrillation.
On May 2, 1994, the Circulatory System Devices Panel of the Medical
Devices Advisory Committee, an FDA advisory committee, reviewed and
recommended approval of the application. On October 28, 1994, 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 [[Page 30090]] 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 July 7, 1995, 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: May 26, 1995.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 95-13827 Filed 6-6-95; 8:45 am]
BILLING CODE 4160-01-F
