97-34157. Vitrophage, Inc.; Premarket Approval of VITREONRegister  

  • [Federal Register Volume 63, Number 1 (Friday, January 2, 1998)]
    [Notices]
    [Pages 88-89]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 97-34157]
    
    
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    DEPARTMENT OF HEALTH AND HUMAN SERVICES
    
    Food and Drug Administration
    [Docket No. 97M-0519]
    
    
    Vitrophage, Inc.; Premarket Approval of VITREON
    
    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 Vitrophage, Inc., Lyons, IL, 
    for premarket approval, under the Federal Food, Drug, and Cosmetic Act 
    (the act), of VITREON . After reviewing the recommendation of 
    the Ophthalmic Devices Panel, FDA's Center for Devices and Radiological 
    Health (CDRH) notified the applicant, by letter of September 30, 1997, 
    of the approval of the application.
    
    DATES: Petitions for administrative review by February 2, 1998.
    
    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: James F. Saviola, Center for Devices 
    and Radiological Health (HFZ-460), Food and Drug Administration, 9200 
    Corporate Blvd., Rockville, MD 20850, 301-594-1744.
    
    SUPPLEMENTARY INFORMATION: On December 6, 1991, Vitrophage, Inc., 
    Lyons, IL 60534, submitted to CDRH an application for premarket 
    approval of VITREON. The device is a purified perfluorocarbon 
    liquid and is indicated for use as an intraoperative surgical aid 
    during vitreoretinal surgery in patients with primary and recurrent 
    complicated retinal detachments. Complicated cases include giant 
    retinal tear or retinal dialysis, proliferative vitreoretinopathy, 
    proliferative diabetic retinopathy, tractional retinal detachments, and 
    blunt or penetrating ocular trauma.
        On October 19, 1995, the Ophthalmic Devices Panel of the Medical 
    Devices Advisory Committee, an FDA advisory committee, reviewed and 
    recommended approval of the application. On September 30, 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 (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 February 2, 1998, file 
    with the Dockets Management Branch (address above) two copies of each 
    petition and supporting data and information,
    
    [[Page 89]]
    
    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: December 1, 1997.
    Joseph A. Levitt,
    Deputy Director for Regulations Policy, Center for Devices and 
    Radiological Health.
    [FR Doc. 97-34157 Filed 12-31-97; 8:45 am]
    BILLING CODE 4160-01-F
    
    
    

Document Information

Published:
01/02/1998
Department:
Food and Drug Administration
Entry Type:
Notice
Action:
Notice.
Document Number:
97-34157
Dates:
Petitions for administrative review by February 2, 1998.
Pages:
88-89 (2 pages)
Docket Numbers:
Docket No. 97M-0519
PDF File:
97-34157.pdf