Federal Register / Vol. 60, No. 82 / Friday, April 28, 1995 / Notices 20999

[Docket No. 95M–0057]

Medtronic CardioRhythm; Premarket

Approval of Atakr Radio Frequency

Catheter Ablation 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 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 § 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

Health Resources and Services

Administration

Advisory Council; Notice of Meeting

In accordance with section 10(a)(2) of

the Federal Advisory Committee Act

(Pub. L. 92–463), announcement is

made of the following National

Advisory bodies scheduled to meet

during the months of May and June

1995.

Name: Advisory Commission on

Childhood Vaccines (ACCV) Subcommittee

on Vaccine Safety.

Date and Time: May 31, 1995; 9:00 am–

5:00 pm.

Place: Parklawn Building, Conference

Room D, 5600 Fishers Lane, Rockville,

Maryland 20857.

The meeting is open to the public.

Purpose: The subcommittee will review

issues relevant to vaccine safety and adverse

reactions to vaccines.

Agenda: Agenda items will include, but

not be limited to: establishing a charge for the

Subcommittee; reviewing current vaccine

safety efforts; and examining the current

status of vaccine safety research.

Name: Advisory Commission on

Childhood Vaccines (ACCV)

Date and Time: June 1, 1995; 9:00 am–5:00

pm.

Place: Parklawn Building, Conference

Room D, 5600 Fishers Lane, Rockville,

Maryland 20857.

Purpose: The Commission: (1) advises the

Secretary on the implementation of the

Program, (2) on its own initiative or as the

result of the filing of a petition, recommends

changes in the Vaccine Injury Table, (3)

advises the Secretary in implementing the

Secretary’s responsibilities under section

2127 regarding the need for childhood

vaccination products that result in fewer or

no significant adverse reactions, (4) surveys

Federal, State, and local programs and

activities relating to the gathering of

information on injuries associated with the

administration of childhood vaccines,

including the adverse reaction reporting

requirements of section 2125(b), and advises

the Secretary on means to obtain, compile,

publish, and use credible data related to the

frequency and severity of adverse reactions

associated with childhood vaccines, and (5)

recommends to the Director of the National

Vaccine Program research related to vaccine

injuries which should be conducted to carry

out the National Vaccine Injury

Compensation Program.

Agenda: Agenda items will include, but

not be limited to: a report on Acellular

Pertussis Vaccine Clinical Trials; a vaccine

safety update from the Centers for Disease

Control and Prevention and the Food and

Drug Administration; and routine Program

reports.

Public comment will be permitted before

the Subcommittee adjourns on May 31; and

at the end of the full Commission meeting on

June 1. Oral presentations will be limited to

5 minutes per public speaker.

Persons interested in providing an oral

presentation should submit a written request,