[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
