[Federal Register Volume 59, Number 164 (Thursday, August 25, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-20983]


[[Page Unknown]]

[Federal Register: August 25, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94M-0269]

 

Toray Industries (America), Inc.; Premarket Approval of the Inoue 
Balloon Catheter

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 Toray Industries (America), Inc., New 
York, NY, for premarket approval, under section 515 of the Federal 
Food, Drug, and Cosmetic Act (the act), of the Inoue Balloon Catheter. 
After reviewing the recommendation of the Circulatory System Devices 
Panel, FDA's Center for Devices and Radiological Health (CDRH) notified 
the applicant, by letter on June 28, 1994, of the approval of the 
application.

DATES: Petitions for administrative review by September 28, 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: Judy J. Danielson, Center for Devices 
and Radiological Health (HFZ-450), Food and Drug Administration, 1390 
Piccard Dr., Rockville, MD 20850, 301-594-1346.

SUPPLEMENTARY INFORMATION: On October 23, 1991, Toray Industries 
(America), Inc., New York, NY 10016, submitted to CDRH an application 
for premarket approval of the Inoue Balloon Catheter. The device is a 
percutaneous valvuloplasty catheter and is indicated for percutaneous 
transvenous mitral commissurotomy in patients with hemodynamically 
significant mitral valvular stenosis resulting primarily from 
commissural fusion of the mitral valve cusps.
    On August 3, 1993, the Circulatory System Devices Panel, an FDA 
Advisory panel, reviewed and recommended approval of the application. 
On June 28, 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 September 26, 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 Director, Center for Devices and Radiological 
Health (21 CFR 5.53).

    Dated: August 10, 1994.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 94-20983 Filed 8-24-94; 8:45 am]
BILLING CODE 4160-01-F