[Federal Register Volume 62, Number 184 (Tuesday, September 23, 1997)]
[Notices]
[Pages 49692-49693]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-25127]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97M-0393]


Avanta Orthopaedics Corp.; Premarket Approval of Braun-Cutter 
Trapezo-metacarpal prosthesis

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 Avanta Orthopaedics Corp., San Diego, 
CA, for premarket approval, under the Federal Food, Drug, and Cosmetic 
Act (the act), of the Braun-Cutter Trapezo-metacarpal Prosthesis. After 
reviewing the recommendation of the Orthopedics and Rehabilitation 
Devices Panel, FDA's Center for Devices and Radiological Health (CDRH) 
notified the applicant, by letter of June 19, 1997, of the approval of 
the application.
DATES: Petitions for administrative review by October 23, 1997.


[[Page 49693]]


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: Theodore R. Stevens, 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 24, 1996, Avanta Orthopaedics 
Corp., San Diego, CA 92121, submitted to CDRH an application for 
premarket approval of the Braun-Cutter Trapezo-metacarpal Prosthesis. 
The device is a finger joint metal/polymer cemented prosthesis and is 
indicated for total joint replacement in skeletally mature patients 
with pain or instability of the trapezo-metacarpal joint due to trauma, 
inflammatory or degenerative disease or revision of previous 
procedures, as an alternative to arthrodesis or reconstructive surgery.
    On June 9, 1997, the Orthopedics and Rehabilitation Devices Panel 
of the Medical Devices Advisory Committee, an FDA advisory committee, 
reviewed and recommended approval of the application. On June 19, 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 (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 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 October 23, 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: August 26, 1997.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 97-25127 Filed 9-22-97; 8:45 am]
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