[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