[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]
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