[Federal Register Volume 62, Number 221 (Monday, November 17, 1997)]
[Notices]
[Page 61339]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-30149]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97M-0459]
Osteonics Corp.; Premarket Approval of the Osteonics Constrained
Acetabular Insert
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 submitted by Osteonics Corp., Allendale,
NJ, for premarket approval, under the Federal Food, Drug, and Cosmetic
Act (the act), of the Osteonics Constrained Acetabular Insert. 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 June 13, 1997, of the approval of
the application.
DATES: Petitions for administrative review by December 17, 1997.
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: Erin I. Keith, Center for Devices and
Radiological Health (HFZ-410), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-2036.
SUPPLEMENTARY INFORMATION: On December 16, 1996, Osteonics Corp.,
Allendale, NJ 07401-1677, submitted to CDRH an application for
premarket approval of the Osteonics Constrained Acetabular Insert. The
device is a constrained hip and is indicated for use as a component of
a total hip prosthesis in primary and revision patients at high risk of
hip dislocation due to a history of prior dislocation, bone loss, joint
or soft tissue laxity, neuromuscular disease, or intraoperative
instability.
On June 10, 1997, the Orthopedic and Rehabilitation Devices Panel
of the Medical Devices Advisory Committee, an FDA advisory committee,
reviewed and recommended approval of the application. On June 13, 1997,
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 Federal Food, Drug, and Cosmetic 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 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 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 December 17, 1997, 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: October 16, 1997.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 97-30149 Filed 11-14-97; 8:45 am]
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