[Federal Register Volume 61, Number 127 (Monday, July 1, 1996)]
[Notices]
[Pages 33926-33927]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-16663]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96M-0193]


Kaneka America Corp.; Premarket Approval of Liposorber LA-15 
System

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 Kaneka America Corp., New York, NY, for 
premarket approval, under the Federal Food, Drug, and Cosmetic Act (the 
act), of the Liposorber LA-15 System. After reviewing the 
recommendation of the Gastroenterology and Urology Devices Panel, FDA's 
Center for Devices and Radiological Health (CDRH) notified the 
applicant, by letter of February 21, 1996, of the approval of the 
application.

DATES: Petitions for administrative review by July 31, 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, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Linda L. Dart, Center for Devices and 
Radiological Health (HFZ-470), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, -301-594-1220.

SUPPLEMENTARY INFORMATION: On October 3, 1991, Kaneka America Corp., 
New York, NY 10022, submitted to CDRH an application for premarket 
approval of the Liposorber LA-15 System. The device is a low density 
lipoprotein (LDL) apheresis system, indicated for use in performing low 
density lipoprotein cholesterol (LDL-C) apheresis to acutely remove 
LDL-C from the plasma of the following high risk patient populations 
for whom diet has been ineffective and maximum drug therapy has either 
been ineffective or not tolerated: Group A--functional 
hypercholesterolemic homozygotes with LDL-C > 500 milligrams/deciliter 
(mg/dL); Group B--functional hypercholesterolemic heterozygotes with 
LDL-C gr-thn-eq 300 mg/dL; and Group C--functional 
hypercholesterolemic heterozygotes with LDL-C gr-thn-eq 200 mg/dL 
and documented coronary heart disease (CHD).
    -The LDL-C levels for the indicated patient populations are 
baseline LDL-C levels obtained after the patient has had, at a minimum, 
a 6-month trial of an American Heart Association Step II diet (or 
equivalent) and maximum tolerated combination drug therapy designed to 
reduce LDL-C. Maximum tolerated combination drug therapy is an adequate 
trial of drugs from at least two separate classes of hypolipidemic 
agents such as, bile acid sequesterants, HMG-CoA reductase inhibitors, 
fibric acid derivatives, niacin/nicotinic acid, etc. Documented CHD 
includes documentation of coronary artery disease by coronary 
angiography or a history of myocardial infarction, coronary artery 
bypass surgery, percutaneous transluminal coronary angioplasty (PTCA) 
or alternative revascularization procedure (e.g., atherectomy or 
stent), or progressive angina documented by exercise or nonexercise 
stress test. Baseline lipid levels are to be determined after 
stabilization on diet and drug therapy by making two measurements 
during a 2- to 4-week period. (Note: the two values should be within 10 
percent of each other, indicating a stable condition.)
    -Although clinical benefit of LDL-C lowering has been documented in 
several diet, drug and/or surgical intervention trials, clinical 
studies using the Liposorber LA-15 System were not designed to address 
and did not establish the long-term clinical benefit of acutely 
lowering LDL-C.
    -On April 21, 1995, the Gastroenterology and Urology Devices Panel 
of the Medical Devices Advisory Committee, an FDA advisory panel, 
reviewed and recommended approval of the application. On February 21, 
1996, 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

[[Page 33927]]

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 the 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 July 31, 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: April 9, 1996.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 96-16663 Filed 6-28-96; 8:45 am]
BILLING CODE 4160-01-F