97-17290. DePuy, Inc.; Premarket Approval of DePuy 1 Bone Cement  

  • [Federal Register Volume 62, Number 127 (Wednesday, July 2, 1997)]
    [Notices]
    [Pages 35821-35822]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 97-17290]
    
    
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    DEPARTMENT OF HEALTH AND HUMAN SERVICES
    
    Food and Drug Administration
    [Docket No. 97M-0255]
    
    
    DePuy, Inc.; Premarket Approval of DePuy 1 Bone Cement
    
    AGENCY: Food and Drug Administration, HHS.
    
    ACTION: Notice.
    
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    SUMMARY: The Food and Drug Administration (FDA) is announcing its
    
    [[Page 35822]]
    
    approval of the application by DePuy, Inc., Warsaw, IN, for premarket 
    approval, under the Federal Food, Drug, and Cosmetic Act (the act), of 
    DePuy 1 Bone Cement. FDA's Center for Devices and Radiological Health 
    (CDRH) notified the applicant, by letter of February 11, 1997, of the 
    approval of the application.
    
    DATES: Petitions for administrative review by August 1, 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: Hany W. Demian, Center for Devices and 
    Radiological Health (HFZ-410), Food and Drug Administration, 9200 
    Corporate Blvd., Rockville, MD 20850, 301-594-2036.
    
    SUPPLEMENTARY INFORMATION: On January 11, 1996, DePuy, Inc., Warsaw, IN 
    46581-0988, (formerly owned by DePuy International Ltd.), submitted to 
    CDRH an application for premarket approval of DePuy 1 Bone Cement. The 
    device is an acrylic bone cement and is indicated for the fixation of 
    prostheses to living bone in orthopedic musculoskeletal surgical 
    procedures for rheumatoid arthritis, osteoarthritis, traumatic 
    arthritis, osteoporosis, avascular necrosis, collagen disease, severe 
    joint destruction secondary to trauma or other conditions and revision 
    of previous arthroplasty.
         In accordance with the provisions of section 515(c)(2) of the act 
    (21 U.S.C. 360e(c)(2)) as amended by the Safe Medical Devices Act of 
    1990, this premarket approval application (PMA) was not referred to the 
    Orthopedic and Rehabilitation Devices Panel of the Medical Devices 
    Advisory Committee, an FDA advisory committee, for review and 
    recommendation because the information in the PMA substantially 
    duplicates information previously reviewed by this panel.
         On February 11, 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 act 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 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 August 1, 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: June 5, 1997.
    Joseph A. Levitt,
    Deputy Director for Regulations Policy, Center for Devices and 
    Radiological Health.
    [FR Doc. 97-17290 Filed 7-1-97; 8:45 am]
    BILLING CODE 4160-01-F
    
    
    

Document Information

Published:
07/02/1997
Department:
Food and Drug Administration
Entry Type:
Notice
Action:
Notice.
Document Number:
97-17290
Dates:
Petitions for administrative review by August 1, 1997.
Pages:
35821-35822 (2 pages)
Docket Numbers:
Docket No. 97M-0255
PDF File:
97-17290.pdf