[Federal Register Volume 59, Number 74 (Monday, April 18, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-9307]
[[Page Unknown]]
[Federal Register: April 18, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94M-0062]
DePuy, Inc.; Premarket Approval of the Rotating Platform
Configuration of the New Jersey LCS Total Knee 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 DePuy, Inc., Warsaw, IN, for premarket
approval, under section 515 of the Federal Food, Drug, and Cosmetic Act
(the act), of the Rotating Platform Configuration of the new jersey
LCS Total Knee System. After reviewing the recommendation of
the Orthopedic and Rehabilitation Devices Panel, FDA's Center for
Devices and Radiological Health (CDRH) notified the applicant, by
letter of February 24, 1994, of the approval of the application.
DATES: Petitions for administrative review by May 18, 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: Paul R. Beninger, Center for Devices
and Radiological Health (HFZ-410), Food and Drug Administration, 1390
Piccard Dr., Rockville, MD 20850, 301-594-1184.
SUPPLEMENTARY INFORMATION: On April 26, 1991, DePuy, Inc., Warsaw, IN
46581-0988, submitted to CDRH an application for premarket approval of
the Rotating Platform Configuration of the new jersey LCS
Total Knee System. The device is indicated for uncemented use in
skeletally mature individuals undergoing primary surgery for
rehabilitating knees damaged as a result of noninflammatory
degenerative joint disease (NIDJD) or either of its composite diagnoses
of osteoarthritis or post-traumatic arthritis. It is indicated for use
in knees whose anterior and posterior cruciate ligaments are absent or
are in such condition as to justify sacrifice.
On November 22, 1991, the Orthopedic and Rehabilitation Devices
Panel of the Medical Devices Advisory Committee, an FDA advisory
committee, reviewed and recommended approval of the application. On
February 24, 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 (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 May 18, 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: April 5, 1994.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 94-9307 Filed 4-15-94; 8:45 am]
BILLING CODE 4160-01-F
