[Federal Register Volume 61, Number 193 (Thursday, October 3, 1996)]
[Notices]
[Pages 51712-51713]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-25260]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 94M-0404]
Thermo Cardiosystems, Inc.; Premarket Approval of the
HeartMate IP LVAS
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 Thermo Cardiosystems, Inc., Woburn, MA,
for premarket approval, under the Federal Food, Drug, and Cosmetic Act
(the act), of HeartMate IP LVAS. After reviewing
[[Page 51713]]
the recommendation of the Circulatory System Devices Panel, FDA's
Center for Devices and Radiological Health (CDRH) notified the
applicant, by letter of September 30, 1994, of the approval of the
application.
DATES: Petitions for administrative review by November 4, 1996.
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: Rhona Shanker, Center for Devices and
Radiological Health (HFZ-450), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-443-8262.
SUPPLEMENTARY INFORMATION: On March, 30 1992, Thermo Cardiosystems,
Inc., Woburn, MA 01888, submitted to CDRH an application for premarket
approval of the HeartMate IP LVAS. The device is a left
ventricular assist device and is indicated for use in patients, who are
on the cardiac transplant list, as temporary mechanical circulatory
support for nonreversible left ventricular failure as a bridge to
cardiac transplantation. The patient should meet all of the following
criteria: (1) Be an approved cardiac transplant candidate; (2) be on
inotropes; (3) be on an intra-aortic balloon pump (if possible); and
(4) have left atrial pressure or pulmonary capillary wedge pressure
20 mmHg with either: a. systolic blood pressure
80 mmHg, or b. cardiac index of 2.0 1/min/
m2.
On December 13, 1993, the Circulatory Devices Panel, an FDA
advisory committee, reviewed and recommended approval of the
application. On September 30, 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 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 November 4, 1996, 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: September 20, 1996.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 96-25260 Filed 10-2-96; 8:45 am]
BILLING CODE 4160-01-F
